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- Obstetrics & Gynecology devices: recent FDA 510(k) clearances

# Obstetrics & Gynecology devices: recent FDA 510(k) clearances

**9 obstetrics & Gynecology devices: recent FDA 510(k) clearances are listed from U.S. FDA openFDA, dated 2026-09-17 to 2026-10-16; the most frequent is Karl Storz SE & CO. KG with 3. 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

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[Free sample: 3 records (CSV)](/v1/verticals/fdapulse/records.csv?panel=Obstetrics%2FGynecology&record_type=clearance)

9 records from U.S. FDA openFDA, dated 2026-09-17 to 2026-10-16. Most frequent: Karl Storz SE & CO. KG (3). 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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Records

9

Most frequent

- Karl Storz SE & CO. KG (3)
- Special Situations, LLC (1)
- Shenzhen TPH Technology Co., Ltd. (1)
- Allwin Medical Devices, Inc. (1)
- Tomy International, Inc. (1)

## How do I get new obstetrics & Gynecology 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=Obstetrics%2FGynecology&record_type=clearance) [Watch this exact filter](/v/fdapulse?panel=Obstetrics%2FGynecology&record_type=clearance#more-ways) [See alert plans](/v/fdapulse#pricing)

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

| Record | Specialty | Type | Date |
|---|---|---|---|
| UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operating Sheath (26205CD) Obturator (26205OC) Shaver Blade (26205SA) Shaver Blade (26205SB) Shaver Blade (091133-01/-10) Shaver Blade (091134-01/-10) (K254252): 510(k) cleared for Karl Storz SE & CO. KG | Obstetrics/Gynecology | 510(k) | 2026-09-25 |
| KARL STORZ SUPRALOOP (K254303): 510(k) cleared for Karl Storz SE & CO. KG | Obstetrics/Gynecology | 510(k) | 2026-09-24 |
| Everslide (K260117): 510(k) cleared for Special Situations, LLC | Obstetrics/Gynecology | 510(k) | 2026-09-23 |
| Wearable Breast Pump (Model S36) (K254203): 510(k) cleared for Shenzhen TPH Technology Co., Ltd. | Obstetrics/Gynecology | 510(k) | 2026-09-17 |
| The D-Tip Denudation Pipette (K261234): 510(k) cleared for Allwin Medical Devices, Inc. | Obstetrics/Gynecology | 510(k) | 2026-10-09 |
| UNIDRIVE Select System (K261102): 510(k) cleared for Karl Storz SE & CO. KG | Obstetrics/Gynecology | 510(k) | 2026-09-18 |
| MODO DUO Electric Pump (B11621, B11673) (K261782): 510(k) cleared for Tomy International, Inc. | Obstetrics/Gynecology | 510(k) | 2026-10-16 |
| Fertilis microICSI Device (K262090): 510(k) cleared for Fertilis Pty, Ltd. | Obstetrics/Gynecology | 510(k) | 2026-10-09 |
| FAMA Male Latex Condoms  Aqueous Lubricant (Ultra-thin);FAMA Male Latex Condoms  Aqueous Lubricant (Plain);FAMA Male Latex Condoms  Aqueous Lubricant (Ribbed);FAMA Male Latex Condoms  Aqueous Lubricant (Dotted);FAMA Male Latex Condoms  Aqueous Lubricant (Non-regular Shaped);MO Male Latex Condom | Obstetrics/Gynecology | 510(k) | 2026-09-21 |

[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) [Neurology devices: recent FDA 510(k) clearances (23)](/hub/fdapulse/specialty_type/neurology--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) [Ophthalmic devices: recent FDA 510(k) clearances (7)](/hub/fdapulse/specialty_type/ophthalmic--510k-clearances)

## Frequently asked questions

### How many obstetrics & Gynecology devices: recent FDA 510(k) clearances are listed?

9 records from U.S. FDA openFDA, last refreshed automatically. The most recent is dated 2026-10-16.

### Can I get alerts for Obstetrics & Gynecology 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)

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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.
