# K963852: Ksea Thermocoagulator (Model 265100 20)

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Dec 10, 1996 after 76 days
- Product code: HGI (Electrocautery, Gynecologic (And Accessories))
- Device class: 2
- Regulation: 21 CFR 884.4120
- 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
The KSEA Thermocoagulator is intended to be used for the laparoscopic treatment of endometriosis, coagulation of biopsy sites, hemostasis, coagulation of blood vessels and separation of adhesions.

Source page: https://510kreport.com/device/K963852
Methodology: https://510kreport.com/methodology