# K000769: Ksea Manhes Pneumotrocar

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Jun 1, 2000 after 84 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
These instruments are manually operated surgical devices intended for making incisions into the patient’s body to establish pneumoperitoneum and allow insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures.

Source page: https://510kreport.com/device/K000769
Methodology: https://510kreport.com/methodology