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# 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): 510(k) cleared for Karl Storz SE & CO. KG vs KARL STORZ SUPRALOOP (K254303): 510(k) cleared for Karl Storz SE & CO. KG: FDAPulse comparison

**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): 510(k) cleared for Karl Storz SE & CO. KG's review days of 270 is 1.0x KARL STORZ SUPRALOOP (K254303): 510(k) cleared for Karl Storz SE & CO. KG's 267 (94th percentile). 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): 510(k) cleared for Karl Storz SE & CO. KG is dated 2026-09-25; KARL STORZ SUPRALOOP (K254303): 510(k) cleared for Karl Storz SE & CO. KG 2026-09-24.**

Data as of 2026-11-04 · [Compiled by Zalwin](/research/fdapulse) from U.S. FDA openFDA (510(k) clearances and device enforcement reports) Copy citation

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## How does 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): 510(k) cleared for Karl Storz SE & CO. KG compare to KARL STORZ SUPRALOOP (K254303): 510(k) cleared for Karl Storz SE & CO. KG?

| Field | 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): 510(k) cleared for Karl Storz SE & CO. KG | KARL STORZ SUPRALOOP (K254303): 510(k) cleared for Karl Storz SE & CO. KG |
|---|---|---|
| Record | 510(k) clearance | 510(k) clearance |
| 510(k) number | K254252 | K254303 |
| Device | 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) | KARL STORZ SUPRALOOP |
| Applicant | Karl Storz SE & CO. KG | Karl Storz SE & CO. KG |
| Specialty / panel | Obstetrics/Gynecology | Obstetrics/Gynecology |
| Product code | HIH | KNF |
| Device class | 2 | 2 |
| Clearance type | Traditional | Traditional |
| Decision | Substantially Equivalent | Substantially Equivalent |
| Received | 2025-12-29 | 2025-12-31 |
| Decision date | 2026-09-25 | 2026-09-24 |
| Review time (days) | 270 | 267 |
| Third-party review | No | No |
| Applicant location | Tuttlingen, DE | Tuttlingen, DE, US |
| amount percentile | 94th | 88th |
| Predicate Speed & CAPA Advisory Opportunity Score | 61/100 | 61/100 |
| Peer rank and all 500 records (CSV) | Every comparable record ranked, with amounts, dates and scores 🔒 Click to unlock → |
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Official records: [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): 510(k) cleared for Karl Storz SE & CO. KG](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254252) · [KARL STORZ SUPRALOOP (K254303): 510(k) cleared for Karl Storz SE & CO. KG](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254303)

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