# K111732: Aquamantys SBS 5.0 Sheated Biopolar Sealer

- Pathway: 510(k) (Traditional)
- Applicant: Salient Surgical Technologies, Inc.
- Decided: Dec 5, 2011 after 168 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.
5 later devices descend from it; 3 cite it directly.
0 of 14 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 1.

## Most influential descendants
- K132974: Aquamantys 2.3 Bipolar Sealer, Evs 4.0 Epidural Vein Sealer, Mini Evs 3.4 Epidural Vein Sealer, SBS 5.0 Sheathed Bipolar (2013), 4 descendants of its own
- K143175: AEx Generator; PlasmaBlade T (2014), 1 descendant of its own
- K211203: Green OR Reprocessed Aquamantys Bipolar Sealer (2022), 0 descendants of its own
- K170381: Minimally Invasive Sealer (MIS) Flex, Minimally Invasive Sealer (MIS) Flex Mini (2017), 0 descendants of its own
- K170610: PlasmaBlade T (2017), 0 descendants of its own

## Indications for use
The Aquamantys SBS 5.0 Sheathed Bipolar Sealer is a sterile, single-use bipolar electrosurgical device intended to be used in conjunction with the Aquamantys Pump Generator for delivery of RIF energy and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for, but not limited to orthopaedlic, spine, endoscopic procedures, abdominal and thoracic surgerj, and epidlural vein sealing during surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

Source page: https://510kreport.com/device/K111732
Methodology: https://510kreport.com/methodology