# K963184: Olympus Subcutaneous Endoscopy System

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Dec 31, 1996 after 139 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
Longest line of descent: 1 generation back to K950076 (1995). 3 ancestors in all.
178 later devices descend from it; 3 cite it directly.
4 of 182 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950076: Laparoscope, Olympus America, Inc. (1995) Summary page 1.
- K950103: Laparoscope, Hand Instruments, Olympus America, Inc. (1995) Summary page 1.
- K955120: Hand-Held Retractor, Dissector & Dissector, Ethicon Endo-Surgery, Inc. (1996) Summary page 1.

## 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

## Indications for use
The Olympus Endoscopic Vessel Harvesting System is specifically designed for subcutaneous endoscopy - - more specifically for endoscopically gaining access to, ligating and/or harvesting vessels (e.g. veins, arteries, ducts, nerve) within the subcutaneous and subfacial surgical planes in the lower extremities.

Source page: https://510kreport.com/device/K963184
Methodology: https://510kreport.com/methodology