# K962246: Rigid Fiber Optic Laparoscope

- Pathway: 510(k) (Traditional)
- Applicant: Health Care International Assoc.
- Decided: Feb 7, 1997 after 241 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
Longest line of descent: 1 generation back to K921883 (1992). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944079: Imagyn Microlap (TM) Laparoscope, Imagyn Medical, Inc. (1995) Summary page 1.
- K950278: Mini Laparoscopy for General Surgery, Olympus America, Inc. (1995) Summary page 1.
- K921883: Endoscope, Optimed Technologies, Inc. (1992) Summary page 1.
- K926597: Laparoscope, Gynecologic (and Accessories), Optimed Technologies, Inc. (1994) Summary page 1.

## Indications for use
Saber’s Rigid Fiber Optic Laparoscopes are used to permit direct viewing of the organs within the peritoneal cavity for the purpose of performing diagnostic and surgical procedures.

Source page: https://510kreport.com/device/K962246
Methodology: https://510kreport.com/methodology