# K943305: Olympus 3D Surgical Endoscopy System

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Nov 17, 1995 after 497 days
- Product code: HET (Laparoscope, Gynecologic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
210 later devices descend from it; 2 cite it directly.
4 of 211 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
- 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
- K062623: Axiom Luminos DRF (2007), 78 descendants of its own

Source page: https://510kreport.com/device/K943305
Methodology: https://510kreport.com/methodology