# K120537: AQUAMANTYS3 9.5 XL Bipolar Sealer

- Pathway: 510(k) (Special)
- Applicant: Medtronic, Inc.
- Decided: May 10, 2012 after 78 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). 12 ancestors in all.
1 later device descends from it; 1 cites 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)
- K101057: Aquamantys Double Cone Bipolar Sealer Model: 23-310-1, Salient Surgical Technologies (2011) Summary page 1.
- K111285: Aquamantys 3 Pump Generator, Bipolar Sealer, Bipolar Sealer with Cutting, Salient Surgical Technologies, Inc. (2011)

## Most influential descendants
- K211203: Green OR Reprocessed Aquamantys Bipolar Sealer (2022), 0 descendants of its own

## Indications for use
The Aquamantys3 9.5 XL Bipolar Sealer is a single use, sterile, bipolar device intended to be used in conjunction with the Aquamantys3 Pump Generator for delivery of radio-frequency (RF) energy and saline for blunt dissection and for haemostatic sealing and coagulation of soft tissue and bone at the operative site. It is intended for, but not limited to, open abdominal, orthopaedic, and thoracic surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

Source page: https://510kreport.com/device/K120537
Methodology: https://510kreport.com/methodology