FDAPulse / report
GANNET® (K262184): 510(k) cleared for BAAT Medical Products B.V.
GANNET® (K262184): 510(k) cleared for BAAT Medical Products B.V.: 510(k) cleared for BAAT Medical Products B.V. Its amount of 115 is below the median of 138 (42nd percentile). Dated 13 days ago, it is in the active follow-up window. Score 42/100. As of 2026-11-03, 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: 115 · 42th percentile of 414 FDAPulse records · 0.8x the median
Free preview: all 14 published fields of this record are shown below. Locked: 2 related NL FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262184 |
| Device | GANNET® |
| Applicant | BAAT Medical Products B.V. |
| Specialty / panel | Orthopedic |
| Product code | JDO |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-06-29 |
| Decision date | 2026-10-22 |
| Review time (days) | 115 |
| Third-party review | No |
| Applicant location | Hengelo, NL |
| amount percentile | 42th of 414 (median 138, 0.8x median) |
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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: 2026-10-22
- Data refreshed: 2026-11-03
- 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: Tue, 03 Nov 2026 18:05:14 GMT
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Peer benchmark and outreach value: GANNET® (K262184): 510(k) cleared for BAAT Medical Products B.V. and 3 NL peers
- NL FDAPulse records like this one: 3
- GANNET® (K262184): 510(k) cleared for BAAT Medical Products B.V.'s amount: 42nd percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every NL peer: $600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
42 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 115-day review: this device is a strong predicate for similar products.
- Posted 13 days ago.
What is the FDAPulse record for GANNET® (K262184): 510(k) cleared for BAAT Medical Products B.V.?
GANNET® (K262184) by BAAT Medical Products B.V. was cleared on 2026-10-22 after 115 days of review.
How does GANNET® (K262184): 510(k) cleared for BAAT Medical Products B.V. compare to other FDAPulse records?
Its amount of 115 is below the median (42th percentile); smaller records often move faster and face less competition. It is fresh: dated 13 days ago, inside the window where early outreach matters most.
GANNET® (K262184) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| GANNET® (K262184) | NL | 2026-10-22 |
| TruVision Single-Use 1.9mm Arthroscopy System (K260156) | UT | 2026-10-09 |
| Kentrospine Viktr-MIS® Pedicle screw system (K252139) | IN | 2026-09-27 |
| F.A.S.T Screw (K254280) | FR | 2026-09-21 |
Related records
- TruVision Single-Use 1.9mm Arthroscopy System (K260156): 510(k) cleared for Nexus CMF, LLC
- Kentrospine Viktr-MIS® Pedicle screw system (K252139): 510(k) cleared for Rivarp Medical Pvt., Ltd.
- F.A.S.T Screw (K254280): 510(k) cleared for Steps Ortho
- The VEGA Cervical Screw System (K254260): 510(k) cleared for GS Medical Co., Ltd.
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- Tempo Plating System (K263407): 510(k) cleared for Pace Surgical
Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Orthopedic devices
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