# K981130: Ksea Endo Tip System

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Aug 19, 1998 after 142 days
- Product code: HET (Laparoscope, Gynecologic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.1720
- 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 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 Ob/Gyn laparoscopic surgical and diagnostic procedures.

Source page: https://510kreport.com/device/K981130
Methodology: https://510kreport.com/methodology