# K972984: Lerner Medical, Inc. Autoclavable 10 MM Laparoscope

- Pathway: 510(k) (Traditional)
- Applicant: Lerner Medical, Inc.
- Decided: Oct 29, 1997 after 79 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 K935818 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K935818: Endoscope, Cuda Products Co. (1994) Summary page 1.

## Indications for use
General Surgery Laparoscopic cholccystectomy, 1lernia repair, Appendectomy, Nisscn fundal plication, Diagnosis and Management of acute abdomeh Thoracie Surgery Pericardiectomy, Pneumonectomy, Evaluation of pulmonary nodule, Biopsy, Plcurodesis

Source page: https://510kreport.com/device/K972984
Methodology: https://510kreport.com/methodology