KARL STORZ SUPRALOOP (K254303): 510(k) cleared for Karl Storz SE & CO. KG
KARL STORZ SUPRALOOP (K254303): 510(k) cleared for Karl Storz SE & CO. KG (Delaware): 510(k) cleared for Karl Storz SE & CO. KG. Its amount of 267 is above the median of 138 (88th percentile). Dated 41 days ago, it serves as a historical benchmark. Score 61/100. 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: 267 · 88th percentile of 414 FDAPulse records · 1.9x the median
Free preview: all 14 published fields of this record are shown below. Locked: 24 related DE FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K254303 |
| Device | KARL STORZ SUPRALOOP |
| Applicant | Karl Storz SE & CO. KG |
| Specialty / panel | Obstetrics/Gynecology |
| Product code | KNF |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2025-12-31 |
| Decision date | 2026-09-24 |
| Review time (days) | 267 |
| Third-party review | No |
| Applicant location | Tuttlingen, DE, US |
| amount percentile | 88th of 414 (median 138, 1.9x median) |
| Peer records CSV (25 DE 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: 2026-09-24
- 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: KARL STORZ SUPRALOOP (K254303): 510(k) cleared for Karl Storz SE & CO. KG and 25 Delaware peers
- Delaware FDAPulse records like this one: 25
- KARL STORZ SUPRALOOP (K254303): 510(k) cleared for Karl Storz SE & CO. KG's amount: 88th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Delaware peer: $5,000 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
61 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 267-day review suggests additional-information requests: a firm likely to value regulatory help next time.
- Posted 41 days ago.
What is the FDAPulse record for KARL STORZ SUPRALOOP (K254303): 510(k) cleared for Karl Storz SE & CO. KG in Delaware?
KARL STORZ SUPRALOOP (K254303) by Karl Storz SE & CO. KG was cleared on 2026-09-24 after 267 days of review.
How does KARL STORZ SUPRALOOP (K254303): 510(k) cleared for Karl Storz SE & CO. KG compare to other Delaware FDAPulse records?
Its amount of 267 sits in the upper half (88th percentile) of 414 records; the median is 138. It is 41 days old, still within a typical 45-day follow-up window.
KARL STORZ SUPRALOOP (K254303) vs. top 2 peers
| Organization | Location | Record date |
|---|---|---|
| KARL STORZ SUPRALOOP (K254303) | DE | 2026-09-24 |
| 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) | DE | 2026-09-25 |
| UNIDRIVE Select System (K261102) | DE | 2026-09-18 |
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