# K950103: Laparoscope, Hand Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Olympus America, Inc.
- Decided: Mar 6, 1995 after 54 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.
357 later devices descend from it; 4 cite it directly.
9 of 358 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
- K963184: Olympus Subcutaneous Endoscopy System (1996), 178 descendants of its own
- K013591: Xenf-TP Rhino-Laryngofiberscope, Its Acessories and Ancillary Equipment (2001), 176 descendants of its own
- K981993: Olympus Integrated Endosurgery System Endoalpha (1998), 175 descendants of its own
- K021073: Visera Rhinlaryngovideoscope Olympus Enf Type V (2002), 160 descendants of its own
- K052452: Visera Rhino-Laryngovideoscope Olympus Enf Type VT (2005), 159 descendants of its own

Source page: https://510kreport.com/device/K950103
Methodology: https://510kreport.com/methodology