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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 vs THERMEO® I MSI (K260031): 510(k) cleared for Pro3Dure Medical GmbH: FDAPulse comparison
THERMEO® I MSI (K260031): 510(k) cleared for Pro3Dure Medical GmbH's review days of 266 is 1.0x 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 258 (86th percentile). 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 is dated 2026-09-15; THERMEO® I MSI (K260031): 510(k) cleared for Pro3Dure Medical GmbH 2026-09-29.
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
Both records plus every comparable record, with all columns and source links · Card, Apple Pay, Google Pay or Link via Stripe
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 THERMEO® I MSI (K260031): 510(k) cleared for Pro3Dure Medical GmbH?
| Field | 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 | THERMEO® I MSI (K260031): 510(k) cleared for Pro3Dure Medical GmbH |
|---|---|---|
| Record | 510(k) clearance | 510(k) clearance |
| 510(k) number | K254299 | K260031 |
| Device | CLEARVISION Irrigation Sheath 0° (7241AS); CLEARVISION Irrigation Sheath 30° (7241BS); CLEARVISION Irrigation Sheath 45° (7241FS) | THERMEO® I MSI |
| Applicant | Karl Storz SE & CO. KG | Pro3Dure Medical GmbH |
| Specialty / panel | Other | Other |
| Product code | EOB | MQC |
| Device class | 2 | U |
| Clearance type | Traditional | Traditional |
| Decision | Substantially Equivalent | Substantially Equivalent |
| Received | 2025-12-31 | 2026-01-06 |
| Decision date | 2026-09-15 | 2026-09-29 |
| Review time (days) | 258 | 266 |
| Third-party review | No | No |
| Applicant location | Tuttlingen, DE | Iserlohn, DE |
| amount percentile | 81st | 86th |
| Predicate Speed & CAPA Advisory Opportunity Score | 55/100 | 61/100 |
| Peer rank and all 500 records (CSV) | 🔒 Click to unlock → | |
| Official source URLs for every peer record | 🔒 Click to unlock → | |
Official records: 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 · THERMEO® I MSI (K260031): 510(k) cleared for Pro3Dure Medical GmbH
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