# K111285: Aquamantys 3 Pump Generator, Bipolar Sealer, Bipolar Sealer with Cutting

- Pathway: 510(k) (Traditional)
- Applicant: Salient Surgical Technologies, Inc.
- Decided: Sep 9, 2011 after 126 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K954171 (1996). 9 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 13 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.
- K944602: Valleylab Force FX, Valleylab, Inc. (1995) Summary page 1.
- K813071: E2508 Disposable Handswitching Pencil, Valleylab, Inc. (1981) Summary page 1.

## Most influential descendants
- K120537: AQUAMANTYS3 9.5 XL Bipolar Sealer (2012), 1 descendant of its own
- K211203: Green OR Reprocessed Aquamantys Bipolar Sealer (2022), 0 descendants of its own
- K121290: AQUAMANTRYS3 BSC 9.1S (2012), 0 descendants of its own

## Recalls of this device
- Nov 12, 2013 · Class II · Z-0905-2014: The internal protection circuitry on the electrosurgical output that prevents a patient from exposure to DC voltage when the device is activated is being compromised during normal use.

## Indications for use
The Aquamantys3 Generator is an electrosurgical generator with monopolar and bipolar RF outputs. It is intended to be used with specified disposables for delivery of RF energy for cutting of soft tissue and RF energy concurrent with saline for haemostatic sealing and coagulation of soft tissue and bone at the operative site during surgical procedures. The system is not intended for contraceptive tubal coagulation (permanent female sterilization). The Aquamantys3 Bipolar Sealer is a bipolar, single use, sterile, disposable device intended for use with the Aquamantys3 Generator. The device delivers bipolar RF energy concurrent with saline for haemostatic sealing and coagulation of soft tissue and bone. 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). The Aquamantys3 8.2L Bipolar Sealer with Cutting is a monopolar/bipolar, single use, sterile, disposable device intended for use with the Aquamantys3 Generator. The device delivers monopolar RF energy for cutting of soft tissue and bipolar RF energy concurrent with saline for haemostatic sealing and coagulation of soft tissue and bone. 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/K111285
Methodology: https://510kreport.com/methodology