# K201151: O-Mec 690 Series Laparoscopes

- Pathway: 510(k) (Traditional)
- Applicant: Omec Medical, Inc.
- Decided: Jun 22, 2020 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
Longest line of descent: 1 generation back to K993045 (1999). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993045: Bariatric Laparoscope, Model 367, Stryker Endoscopy (1999) Summary page 4.

## Most influential descendants
- K231725: Laparoscope (4KA0, 4KA0R, 4KA30, 4KA30R, 4KA45, 4KA45R) (2023), 0 descendants of its own
- K231003: Laparoscope (21033FA, 21033FC, 21033WA, 21033WC, 20533FA, 20533FC, 20533WA, 20533WC) (2023), 0 descendants of its own

## Indications for use
The O-Mec Laparoscopes 690 Series (Models, 90-331000H, 690-331030H, 690-300500H, 690-300530H) are intended to be used by surgeons in diagnostic and therapeutic procedures. Laparoscopic minimally invasive procedures are performed in the abdominal cavity by means of small skin punctures that allow the insertion of the laparoscope and laparoscopic instruments.

Source page: https://510kreport.com/device/K201151
Methodology: https://510kreport.com/methodology