# K151822: ab medica irrigation/suction gravity system

- Pathway: 510(k) (Traditional)
- Applicant: Ab Medica Sas
- Decided: Sep 4, 2015 after 60 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 K930512 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935826: Laparoscopic/Suction/Irrigation Probe, Core Dynamics, Inc. (1994) Summary page 4.
- K930512: Suction/Irrigation Y Tubing Set W/Trumpet Valves, Core Dynamics, Inc. (1993) Summary page 4.

## Indications for use
ab medica Irrigation/Suction Gravity System is indicated for use in gynecological laparoscopy, laparoscopic cholecystectomy and other laparoscopic procedures.

Source page: https://510kreport.com/device/K151822
Methodology: https://510kreport.com/methodology