# K101193: PMC Laparoscopic Instruments

- Pathway: 510(k) (Traditional)
- Applicant: Pmc Medical GmbH
- Decided: Oct 18, 2010 after 173 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: 3 generations back to K931340 (1993). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012660: Gimmi'alpha' Endoscopes & Accessories, Gimmi GmbH (2001) Summary page 1.
- K080257: Microfrance Laparoscopic Manual Surgical Instruments, Medtronic Xomed, Inc. (2008) Summary page 1.

## Indications for use
Laparoscopes are 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. The PMC Laparoscopic instruments are intended to scrape, cut, grasp, hold, remove, and manipulate tissue, organs or bowel during laparoscopic surgery. The secondary function is to provide monopolar electrocautery capability to dissect and coagulate soft tissue.

Source page: https://510kreport.com/device/K101193
Methodology: https://510kreport.com/methodology