CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS) (K254299): 510(k) cleared for Karl Storz SE & CO. KG
CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS) (K254299): 510(k) cleared for Karl Storz SE & CO. KG (Delaware): 510(k) cleared for Karl Storz SE & CO. KG. Its amount of 258 is above the median of 138 (81st percentile). Dated 50 days ago, it serves as a historical benchmark. Score 55/100. 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: 258 · 81th 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 | K254299 |
| Device | CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS) |
| Applicant | Karl Storz SE & CO. KG |
| Specialty / panel | Other |
| Product code | EOB |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2025-12-31 |
| Decision date | 2026-09-15 |
| Review time (days) | 258 |
| Third-party review | No |
| Applicant location | Tuttlingen, DE |
| amount percentile | 81th of 414 (median 138, 1.9x median) |
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- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-09-15
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
Top FDAPulse records (DE first): colonic FTRD Set (200.70); diagnostic FTRD Set (200.76); gas · Endox High Level Disinfectant (K254094) · Actolind® (06.3637. Actolind® Gel Plus) (K254168) · UNIDRIVE SIII System; HOPKINS Telescope 0º (26205AMA) Operat · KARL STORZ SUPRALOOP (K254303) · Browse all by state and category →
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: CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS) (K254299): 510(k) cleared for Karl Storz SE & CO. KG and 25 Delaware peers
- Delaware FDAPulse records like this one: 25
- CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS) (K254299): 510(k) cleared for Karl Storz SE & CO. KG's amount: 81st 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)
55 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 258-day review suggests additional-information requests: a firm likely to value regulatory help next time.
What is the FDAPulse record for CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS) (K254299): 510(k) cleared for Karl Storz SE & CO. KG in Delaware?
CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS) (K254299) by Karl Storz SE & CO. KG was cleared on 2026-09-15 after 258 days of review.
How does CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS) (K254299): 510(k) cleared for Karl Storz SE & CO. KG compare to other Delaware FDAPulse records?
Its amount of 258 sits in the upper half (81th percentile) of 414 records; the median is 138. It is 50 days old; check the official source for later updates before acting.
CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS) (K254299) vs. top 2 peers
| Organization | Location | Record date | Compare |
|---|---|---|---|
| CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS) (K254299) | DE | 2026-09-15 | This record |
| THERMEO® I MSI (K260031) | DE | 2026-09-29 | Compare CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS) (K254299) vs THERMEO® I MSI (K260031) → |
| Actolind® (06.3637. Actolind® Gel Plus) (K254168) | DE | 2026-09-22 | View record → |
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