# K092149: Boss Coagulation Device, Model BOSS1215, Boss Coagulation Device, Angled Access, Model BOSA1215

- Pathway: 510(k) (Traditional)
- Applicant: Bovie Medical
- Decided: Mar 18, 2010 after 245 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: 5 generations back to K954171 (1996). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052859: Aquamantys Pump Generator System, Tissuelink Medical, Inc. (2005) Summary page 1.
- K063639: Aquamantys SS4.0 Bipolar Sealer, Model 23-121-1, Tissuelink Medical, Inc. (2007) Summary page 3.

## Indications for use
BOSS Bipolar Operative Saline-Enhanced Sintered Steel Coagulation Devices are sterile, single-use bipolar electrosurgical devices intended to deliver RF energy and saline for coagulation of soft tissue and bone at the operative site. It is intended for but not limited to orthopedic, spine, endloscopic procedures, abdominal and thoracic surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

Source page: https://510kreport.com/device/K092149
Methodology: https://510kreport.com/methodology