# K980694: Ksea Plastic Trocars

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: May 8, 1998 after 74 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 manually operated surgical devices intended for making incisions into the patient’s body to allow insertion of endoscopes and endoscopic accessories during Ob/Gyn laparoscopic procedures.

Source page: https://510kreport.com/device/K980694
Methodology: https://510kreport.com/methodology