UNIDRIVE SIII System +1 more— 510(k) K254252
Substantially EquivalentKarl Storz SE & CO. KG
FDA 510(k) clearance K254252 for UNIDRIVE SIII System +1 more, Substantially Equivalent on 2026-09-25. Applicant: Karl Storz SE & CO. KG. Device class: 2.
Summary
Karl Storz SE & Co. KG cleared a hysteroscopy setup under HIH, hysteroscopes and accessories. The file lists the UNIDRIVE S III system, a HOPKINS 0-degree telescope (26205AMA), an operating sheath, an obturator, and several shaver blades by part number. The record doesn't state the indications.
Class II, 21 CFR 884.1690. The Obstetrics/Gynecology panel reviewed it as a Traditional 510(k).
Karl Storz filed from Tuttlingen, Germany. Review took 270 days (December 29, 2025 to September 25, 2026).
Clearance details
- Device name as filed
- 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)
- 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- K261102 — UNIDRIVE Select System
- 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.