# UNIDRIVE Select System (K261102): 510(k) cleared for Karl Storz SE & CO. KG

**Predicate Speed & CAPA Advisory Opportunity Score:** 42/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K261102 |
| Device | UNIDRIVE Select System |
| Applicant | Karl Storz SE & CO. KG |
| Specialty / panel | Obstetrics/Gynecology |
| Product code | HIH |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-04-03 |
| Decision date | 2026-09-18 |
| Review time (days) | 168 |
| Third-party review | No |
| Applicant location | Tuttlingen, DE |

## Why this score
- 168-day review, longer than typical.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261102). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.