Durashield Device Kit (K252995): 510(k) cleared for SurGenTec, LLC
Durashield Device Kit (K252995): 510(k) cleared for SurGenTec, LLC (Florida): 510(k) cleared for SurGenTec, LLC. Its amount of 364 is top-decile (98th percentile of 414 records). Dated 49 days ago, it serves as a historical benchmark. Score 55/100. 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: 364 · 98th percentile of 414 FDAPulse records · 2.6x the median
Free preview: all 14 published fields of this record are shown below. Locked: 15 related FL FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K252995 |
| Device | Durashield Device Kit |
| Applicant | SurGenTec, LLC |
| Specialty / panel | Neurology |
| Product code | GZT |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2025-09-18 |
| Decision date | 2026-09-17 |
| Review time (days) | 364 |
| Third-party review | No |
| Applicant location | Boca Raton, FL, US |
| amount percentile | 98th of 414 (median 138, 2.6x median) |
| Peer records CSV (16 FL records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 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: 2026-09-17
- 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 21:30:53 GMT
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Peer benchmark and outreach value: Durashield Device Kit (K252995): 510(k) cleared for SurGenTec, LLC and 16 Florida peers
- Florida FDAPulse records like this one: 16
- Durashield Device Kit (K252995): 510(k) cleared for SurGenTec, LLC's amount: 98th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Florida peer: $3,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
55 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 364-day review suggests additional-information requests: a firm likely to value regulatory help next time.
What is the FDAPulse record for Durashield Device Kit (K252995): 510(k) cleared for SurGenTec, LLC in Florida?
Durashield Device Kit (K252995) by SurGenTec, LLC was cleared on 2026-09-17 after 364 days of review.
How does Durashield Device Kit (K252995): 510(k) cleared for SurGenTec, LLC compare to other Florida FDAPulse records?
This is a top-decile record: its amount of 364 is 2.6x the median of 138 across 414 records. It is 49 days old; check the official source for later updates before acting.
Durashield Device Kit (K252995) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Durashield Device Kit (K252995) | FL | 2026-09-17 |
| 7D Surgical System (10-0001) (K260403) | CA | 2026-10-19 |
| cCeLL - In vivo (K260315) | KR | 2026-10-16 |
| Neurora (K260064) | NH | 2026-10-02 |
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