ACHM30 AtriClip FLEX-Mini LAA Exclusion System (K263319): 510(k) cleared for AtriCure, Inc.
ACHM30 AtriClip FLEX-Mini LAA Exclusion System (K263319): 510(k) cleared for AtriCure, Inc. (Ohio): 510(k) cleared for AtriCure, Inc. Its amount of 30 is below the median of 138 (10th percentile). Dated 15 days ago, it is in the active follow-up window. Score 41/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 30 · 10th percentile of 414 FDAPulse records · 0.2x the median
Free preview: all 14 published fields of this record are shown below. Locked: 24 related OH FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K263319 |
| Device | ACHM30 AtriClip FLEX-Mini LAA Exclusion System |
| Applicant | AtriCure, Inc. |
| Specialty / panel | General, Plastic Surgery |
| Product code | PZX |
| Device class | 2 |
| Clearance type | Special |
| Decision | Substantially Equivalent |
| Received | 2026-09-21 |
| Decision date | 2026-10-21 |
| Review time (days) | 30 |
| Third-party review | No |
| Applicant location | Mason, OH, US |
| amount percentile | 10th of 414 (median 138, 0.2x median) |
| Peer records CSV (25 OH records) | 🔒 Click to unlock → |
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CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-10-21
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
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Peer benchmark and outreach value: ACHM30 AtriClip FLEX-Mini LAA Exclusion System (K263319): 510(k) cleared for AtriCure, Inc. and 25 Ohio peers
- Ohio FDAPulse records like this one: 25
- ACHM30 AtriClip FLEX-Mini LAA Exclusion System (K263319): 510(k) cleared for AtriCure, Inc.'s amount: 10th percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every Ohio peer: $5,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
41 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 30-day review: this device is a strong predicate for similar products.
- Special 510(k): a modification of an existing device.
- Posted 15 days ago.
What is the FDAPulse record for ACHM30 AtriClip FLEX-Mini LAA Exclusion System (K263319): 510(k) cleared for AtriCure, Inc. in Ohio?
ACHM30 AtriClip FLEX-Mini LAA Exclusion System (K263319) by AtriCure, Inc. was cleared on 2026-10-21 after 30 days of review.
How does ACHM30 AtriClip FLEX-Mini LAA Exclusion System (K263319): 510(k) cleared for AtriCure, Inc. compare to other Ohio FDAPulse records?
Its amount of 30 is below the median (10th percentile); smaller records often move faster and face less competition. It is 15 days old, still within a typical 45-day follow-up window.
ACHM30 AtriClip FLEX-Mini LAA Exclusion System (K263319) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| ACHM30 AtriClip FLEX-Mini LAA Exclusion System (K263319) | OH | 2026-10-21 |
| TECAR Therapy Device (TC2000, TC2001) (K252288) | CN | 2026-10-13 |
| easyEndo E-Lite Single Use Powered Endoscopic Staplers; easyEndo E-Lite Single Use Powered Endoscopic Staplers with Curved Tip; easyEndo E-Lite Single Use Cartridges (K254291) | CN | 2026-09-25 |
| PicoreMax (PicoreMax) (K254199) | KR | 2026-09-24 |
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