# K944201: HI-Q Hand Instruments- Urology

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Nov 29, 1994 after 92 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
216 later devices descend from it; 3 cite it directly.
4 of 217 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K972114: Olympus Sonosurg System (1998), 213 descendants of its own
- K981993: Olympus Integrated Endosurgery System Endoalpha (1998), 175 descendants of its own
- K994231: Siemens Integrated Operating System (Sios) (2000), 157 descendants of its own
- K052202: Axiom Artis - Modular Angiographic System (2006), 154 descendants of its own
- K061054: Axiom Aristos FX Plus (2006), 80 descendants of its own

Source page: https://510kreport.com/device/K944201
Methodology: https://510kreport.com/methodology