# K223520: UNIDRIVE SIII System

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz-Endoscopy-America, Inc.
- Decided: Apr 27, 2023 after 155 days
- Product code: HIH (Hysteroscope (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1690
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K953695 (1995). 9 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132015: Truclear Morcellation System and Truclear Morcellators, Smith & Nephew, Inc. (2013) Summary page 4.
- K935716: Karl Storz Fixed Magnification Telescope/KS Variable Magnification Telescope, KARL STORZ Endoscopy-America, Inc. (1995) Summary page 4.

## Most influential descendants
- K254252: 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) (2026), 0 descendants of its own
- K261102: UNIDRIVE Select System (2026), 0 descendants of its own

## Indications for use
The UNIDRIVE SIII System is intended for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue. The HOPKINS Telescope when used with the obturator is intended to permit viewing of the cervical canal and uterine cavity for the purpose of performing diagnostic and surgical procedures.

Source page: https://510kreport.com/device/K223520
Methodology: https://510kreport.com/methodology