# 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)

- Pathway: 510(k) (Traditional)
- Applicant: Karl Storz SE & CO. KG
- Decided: Sep 25, 2026 after 270 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: 5 generations back to K953695 (1995). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223520: UNIDRIVE SIII System, Karl Storz-Endoscopy-America, Inc. (2023) Summary page 5.

## Indications for use
The UNIDRIVE S Ill system is intended for intrauterine use by trained gynecologists to hysteroscopically resect and remove tissue. The HOPKINS Telescope when used with the obturator and sheath 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/K254252
Methodology: https://510kreport.com/methodology