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- Neurology devices: recent FDA 510(k) clearances

# Neurology devices: recent FDA 510(k) clearances

**23 neurology devices: recent FDA 510(k) clearances are listed from U.S. FDA openFDA, dated 2026-09-11 to 2026-10-22; the most frequent is VPIX Medical, Inc. with 2. Data last updated 2026-11-04; each record links to its official source and a full report.**

Data as of 2026-11-04 · [Compiled by Zalwin](/research/fdapulse) from U.S. FDA openFDA Copy citation

Download all 23 neurology devices: recent FDA 510(k) clearances (CSV) — $4.99 →

Includes: Record, Specialty, Date, Review days, Recall class, official source URL and score · Card, Apple Pay, Google Pay or Link via Stripe

[Free sample: 3 records (CSV)](/v1/verticals/fdapulse/records.csv?panel=Neurology&record_type=clearance)

23 records from U.S. FDA openFDA, dated 2026-09-11 to 2026-10-22. Most frequent: VPIX Medical, Inc. (2). Each record links to a full report and the official source.

Last updated 2026-11-04. Source: U.S. FDA openFDA.

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[Run instant live search with these filters](/v/fdapulse?panel=Neurology&record_type=clearance&channel=pseo#vt-out) [Download free 3-row sample CSV](/v1/verticals/fdapulse/records.csv?panel=Neurology&record_type=clearance)

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Records

23

Most frequent

- VPIX Medical, Inc. (2)
- 7D Surgical ULC (1)
- Argus Cognitive, Inc. (1)
- Aesculap, Inc. (1)
- SurGenTec, LLC (1)

## How do I get new neurology devices: recent FDA 510(k) clearances by email?

Search, filter and export these records, or get alerts when new ones appear.

[Search and filter](/v/fdapulse?panel=Neurology&record_type=clearance) [Watch this exact filter](/v/fdapulse?panel=Neurology&record_type=clearance#more-ways) [See alert plans](/v/fdapulse#pricing)

## What are the top neurology devices: recent FDA 510(k) clearances right now?

| Record | Specialty | Type | Date |
|---|---|---|---|
| 7D Surgical System (10-0001) (K260403): 510(k) cleared for 7D Surgical ULC | Neurology | 510(k) | 2026-10-19 |
| cCeLL - In vivo (K260315): 510(k) cleared for VPIX Medical, Inc. | Neurology | 510(k) | 2026-10-16 |
| Neurora (K260064): 510(k) cleared for Argus Cognitive, Inc. | Neurology | 510(k) | 2026-10-02 |
| Ventricular Catheters, Thomale Catheter (K260044): 510(k) cleared for Aesculap, Inc. | Neurology | 510(k) | 2026-10-02 |
| cCeLL405 (K254030): 510(k) cleared for VPIX Medical, Inc. | Neurology | 510(k) | 2026-10-02 |
| Durashield Device Kit (K252995): 510(k) cleared for SurGenTec, LLC | Neurology | 510(k) | 2026-09-17 |
| Disposable Sterile Skull Drill (LZ) (K254177): 510(k) cleared for Guizhou Zirui Technology Co., Ltd. | Neurology | 510(k) | 2026-09-11 |
| FAQ (FAQ 411) (K261565): 510(k) cleared for Foreo, Inc. | Neurology | 510(k) | 2026-10-22 |
| Wireless TENS&EMS&NMES Heating Stimulator (SM9086, SM9125, SM9141B, SM9142B, SM9143) (K261574): 510(k) cleared for Hong Qiangxing (Shenzhen) Electronics Limited | Neurology | 510(k) | 2026-10-16 |
| KARL STORZ Flexible Video Neuro-Endoscope (K260581): 510(k) cleared for Karl Storz SE & CO. KG | Neurology | 510(k) | 2026-10-14 |
| Sleep Analysis Module (K261521): 510(k) cleared for Neurotronics, LLC | Neurology | 510(k) | 2026-10-09 |
| Tontarra Punches and Rongeurs (K260446): 510(k) cleared for Tontarra Medizintechnik GmbH | Neurology | 510(k) | 2026-09-15 |
| TMINI Miniature Robotic System (K263234): 510(k) cleared for THINK Surgical, Inc. | Neurology | 510(k) | 2026-10-16 |
| CarboClear® Cervical Navigated Instruments (K263154): 510(k) cleared for CarboFix Orhtopedics , Ltd. | Neurology | 510(k) | 2026-10-09 |
| ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress (K263010): 510(k) cleared for inomed Medizintechnik GmbH | Neurology | 510(k) | 2026-09-24 |
| Rongjian Self-adhesive Electrode (K262664): 510(k) cleared for Bozhou Rongjian Medical Appliance Co., Ltd. | Included in the full CSV with every column 🔒 Unlock all 23 records → |
| Sway System (Sports Plus) (K262000): 510(k) cleared for Sway Medical, Inc. | Included in the full CSV with every column 🔒 Unlock all 23 records → |
| Disposable Reflective Marker Spheres (AM-BK115S, AM-BL130S) (K262214): 510(k) cleared for Guangzhou Aimooe Technology Co., Ltd. | Included in the full CSV with every column 🔒 Unlock all 23 records → |

Browse 8 more matching record reports
- [Rongjian Self-adhesive Electrode (K262664): 510(k) cleared for Bozhou Rongjian Medical Appliance Co., Ltd.](/report/fdapulse/rongjian-self-adhesive-electrode-k262664-cn--k262664)
- [Sway System (Sports Plus) (K262000): 510(k) cleared for Sway Medical, Inc.](/report/fdapulse/sway-system-sports-plus-k262000-ok--k262000)
- [Disposable Reflective Marker Spheres (AM-BK115S, AM-BL130S) (K262214): 510(k) cleared for Guangzhou Aimooe Technology Co., Ltd.](/report/fdapulse/disposable-reflective-marker-spheres-am-bk115s-am-bl130s-cn--k262214)
- [NEXT-Cue (K261805): 510(k) cleared for Neuroxt, Inc.](/report/fdapulse/next-cue-k261805-kr--k261805)
- [Spine Planning (3.0); Spine & Trauma Navigation; Alignment System Spine (K262257): 510(k) cleared for Brainlab SE](/report/fdapulse/spine-planning-3-0-spine-and-trauma-navigation-alignment-de--k262257)
- [CraniUS Plate (K262874): 510(k) cleared for CraniUS, LLC](/report/fdapulse/cranius-plate-k262874-md--k262874)
- [LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)) (K261370): 510(k) cleared for Guangdong Newdermo Biotech Co., Ltd.](/report/fdapulse/led-light-therapy-masks-led-face-mask-pulse-fac06na-k261370-cn--k261370)
- [Ceribell EEG Analysis Software (K261712): 510(k) cleared for Ceribell, Inc.](/report/fdapulse/ceribell-eeg-analysis-software-k261712-ca--k261712)

[Browse all FDAPulse record reports](/hub/fdapulse/records)

## Which related categories and locations should I check?

### Browse by record type

[510(k) clearances (414)](/hub/fdapulse/type/510k-clearances) [Class II device recalls (320)](/hub/fdapulse/type/class-ii-recalls) [Class I device recalls (19)](/hub/fdapulse/type/class-i-recalls) [Class III device recalls (11)](/hub/fdapulse/type/class-iii-recalls)

### Browse by specialty

[Radiology (56)](/hub/fdapulse/specialty/radiology) [Orthopedic (53)](/hub/fdapulse/specialty/orthopedic) [Cardiovascular (52)](/hub/fdapulse/specialty/cardiovascular) [General & Plastic Surgery (44)](/hub/fdapulse/specialty/general-plastic-surgery) [Dental (32)](/hub/fdapulse/specialty/dental) [Gastroenterology & Urology (27)](/hub/fdapulse/specialty/gastroenterology-urology) [Neurology (23)](/hub/fdapulse/specialty/neurology) [Microbiology (21)](/hub/fdapulse/specialty/microbiology) [Clinical Chemistry (15)](/hub/fdapulse/specialty/clinical-chemistry) [General Hospital (14)](/hub/fdapulse/specialty/general-hospital) [Anesthesiology (12)](/hub/fdapulse/specialty/anesthesiology) [Obstetrics & Gynecology (9)](/hub/fdapulse/specialty/obstetrics-gynecology) [Ophthalmic (7)](/hub/fdapulse/specialty/ophthalmic)

### Browse by record type by specialty

[Radiology devices: recent FDA 510(k) clearances (56)](/hub/fdapulse/specialty_type/radiology--510k-clearances) [Orthopedic devices: recent FDA 510(k) clearances (53)](/hub/fdapulse/specialty_type/orthopedic--510k-clearances) [Cardiovascular devices: recent FDA 510(k) clearances (52)](/hub/fdapulse/specialty_type/cardiovascular--510k-clearances) [General & Plastic Surgery devices: recent FDA 510(k) clearances (44)](/hub/fdapulse/specialty_type/general-plastic-surgery--510k-clearances) [Dental devices: recent FDA 510(k) clearances (32)](/hub/fdapulse/specialty_type/dental--510k-clearances) [Gastroenterology & Urology devices: recent FDA 510(k) clearances (27)](/hub/fdapulse/specialty_type/gastroenterology-urology--510k-clearances) [Microbiology devices: recent FDA 510(k) clearances (21)](/hub/fdapulse/specialty_type/microbiology--510k-clearances) [Clinical Chemistry devices: recent FDA 510(k) clearances (15)](/hub/fdapulse/specialty_type/clinical-chemistry--510k-clearances) [General Hospital devices: recent FDA 510(k) clearances (14)](/hub/fdapulse/specialty_type/general-hospital--510k-clearances) [Anesthesiology devices: recent FDA 510(k) clearances (12)](/hub/fdapulse/specialty_type/anesthesiology--510k-clearances) [Obstetrics & Gynecology devices: recent FDA 510(k) clearances (9)](/hub/fdapulse/specialty_type/obstetrics-gynecology--510k-clearances) [Ophthalmic devices: recent FDA 510(k) clearances (7)](/hub/fdapulse/specialty_type/ophthalmic--510k-clearances)

## Frequently asked questions

### How many neurology devices: recent FDA 510(k) clearances are listed?

23 records from U.S. FDA openFDA, last refreshed automatically. The most recent is dated 2026-10-22.

### Can I get alerts for Neurology devices: recent FDA 510(k) clearances?

Yes. FDAPulse can email you new records matching this filter; plans are listed on the FDAPulse page.

Source: U.S. FDA openFDA. Informational only. [RSS feed of new records](/feed/fdapulse.xml)

## Often used together

- [NPIPulse](/v/npipulse)
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Or get the [Healthcare Vendor Bundle](/v/fdapulse#more-ways) for $14.99 one-time: Full CSV unlocks for group practices and FDA clearances/recalls.
