UNIDRIVE Select System— 510(k) K261102
Substantially EquivalentKarl Storz SE & CO. KG
FDA 510(k) clearance K261102 for UNIDRIVE Select System, Substantially Equivalent on 2026-09-18. Applicant: Karl Storz SE & CO. KG. Device class: 2.
Summary
UNIDRIVE Select System is a Karl Storz SE & CO. KG submission under product code HIH (Hysteroscope (And Accessories)). The record doesn't describe the system beyond its name and code.
Class II, 21 CFR 884.1690. Obstetrics/Gynecology is both the classification panel and the review panel, and it came in as a Traditional 510(k). The decision was Substantially Equivalent.
Karl Storz filed from Tuttlingen, Germany. The decision came 168 calendar days after receipt (April 3 to September 18, 2026).
Clearance details
- Applicant
- Karl Storz SE & CO. KG
- Product code
- Product code HIH
- Device class
- Class 2
- Regulation
- 21 CFR 884.1690
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tuttlingen, DE
Recent devices under product code HIH
view all- K254252 — UNIDRIVE SIII System +1 more
- K254294 — Single-use Digital Hysteroscope (GYUT-A 12.6- 0, GYUT-A12.6- 12, GYUT-A 12.6- 22, GYUT-A 12.6- 30, GYUT-A 14.4- 0, GYUT-A 14.4- 12,GYUT-A 14.4- 22, GYUT-A 14.4- 30, GYUT-B 15- 0, GYUT-B 15- 12, GYUT-B 15-22, GYUT-B 15- 30)
- K260984 — HERizon RD5 Resecting Device (5FR1PK); HERizon RD5 Resecting Device - 5 pack (5FR5PK)
- K253020 — Strauss Surgical Resection Instruments
- K254050 — Manual Tissue Removal Device
More clearances from Karl Storz SE & CO. KG
view allAdverse events under product code HIH
product code HIH- Death
- 18
- Injury
- 973
- Malfunction
- 5,071
- Other
- 1
- Total
- 6,063
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.