# K973909: Ksea Endotip System

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Feb 27, 1998 after 136 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
These instruments are intended for use by qualified surgeons or physicians to provide access to the patient’s body and allow insertion of endoscopes and endoscopic accessories during general endoscopic and laparoscopic procedures.

Source page: https://510kreport.com/device/K973909
Methodology: https://510kreport.com/methodology