# K030380: Tissuelink Sealing Forceps, Model 1 21-202-1

- Pathway: 510(k) (Special)
- Applicant: Tissuelink Medical, Inc.
- Decided: Mar 3, 2003 after 26 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- 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 its predicate without a number.
- (no number) TissueLink Bipolar Forceps: named in the summary without a submission number

## Indications for use
The TissueLink Sealing Forceps (Bipolar Forceps) is a sterile, single use bipolar electrosurgical device intended to be used in general and thoracic electrosurgical applications for coagulating, sealing and transecting tissue. It is intended for, but not limited to abdominal and thoracic surgery, Iaparoscopic procedures, endoscopic procedures and thoracoscopic procedures. The device is not intended for contraceptive tubal coagulation (permanent female sterilization.)

Source page: https://510kreport.com/device/K030380
Methodology: https://510kreport.com/methodology