# K121290: AQUAMANTRYS3 BSC 9.1S

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Jun 25, 2012 after 56 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). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111285: Aquamantys 3 Pump Generator, Bipolar Sealer, Bipolar Sealer with Cutting, Salient Surgical Technologies, Inc. (2011)

## Indications for use
The Aquamantys3 BSC 9.1 S is a monopolar/bipolar, single use, sterile, disposable device intended for use with the Aquamantys3 Pump Generator. The device delivers bipolar RE energy concurrent with saline for haemostatic sealing and coagulation of soft tissue and bone and monopolar REF energy for cutting of soft tissue. It is intended for, but not limited to, orthopaedic, spine, thoracic, and open abdominal surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

Source page: https://510kreport.com/device/K121290
Methodology: https://510kreport.com/methodology