# K102983: Vascuclear Precision Bipolar

- Pathway: 510(k) (Special)
- Applicant: Sorin Group USA, Inc.
- Decided: Nov 1, 2010 after 25 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
Longest line of descent: 1 generation back to K003587 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003587: Clearglide Precision Bipolar Device, ETHICON, Inc. (2000) Summary page 1.

## Indications for use
The VascuClear Precision Bipolar is intended for endoscopic and open tissue dissection, bipolar coagulation, and transection of vessels.

Source page: https://510kreport.com/device/K102983
Methodology: https://510kreport.com/methodology