# K132974: Aquamantys 2.3 Bipolar Sealer, Evs 4.0 Epidural Vein Sealer, Mini Evs 3.4 Epidural Vein Sealer, SBS 5.0 Sheathed Bipolar

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Advanced Energy, LLC
- Decided: Dec 3, 2013 after 71 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: 6 generations back to K954171 (1996). 10 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K896541: Malis Bipolar Electrosurgical System CMC-Iii, Valley Forge Scientific Corp. (1990) Summary page 1.
- 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.
- K111732: Aquamantys SBS 5.0 Sheated Biopolar Sealer, Salient Surgical Technologies, Inc. (2011) Summary page 1.
- (no number) Codman Irrigated Bipolar Forceps: named in the summary without a submission number

## Most influential descendants
- 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 2.3 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 orthiopaedic, neurosurgical, spine, thoracic, and open abdominal surgery. The device is not Intended for contraceptive tubal coagulation (permanent female sterilization). The Aquamantys Epidural Vein Sealer is a sterile, singte-use bipolar electrosurgical device intended to be used in conijunction 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 orthopaedic, neurosurgical, spine, endoscopic procedures, abdominal and thoracic surgery, and epidural vein sealing during surgery. The device is not Intended for contraceptive tubal coagulation (permanent female sterilization). The Aquamantys 585 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 RF energy and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative shte. It is Intended for, but not limited to orthopaedic. neurosurgical, spine, endoscopic procedures, abdominal and thoracic surgery, and epidural vein sealing during surgery. The device Is not intended for contraceptive tubal coagulation (permanent female sterilization).

Source page: https://510kreport.com/device/K132974
Methodology: https://510kreport.com/methodology