# K101057: Aquamantys Double Cone Bipolar Sealer Model: 23-310-1

- Pathway: 510(k) (Traditional)
- Applicant: Salient Surgical Technologies
- Decided: Apr 5, 2011 after 355 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: 4 generations back to K954171 (1996). 8 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014260: Tissuelink Solid Cylinder Monopolar Device, Tissuelink Medical, Inc. (2002) Summary page 1.
- K052859: Aquamantys Pump Generator System, Tissuelink Medical, Inc. (2005) 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
- K123201: Aquamantys Endo DBS 8.7 Dissecting Bipolar Sealer (2013), 0 descendants of its own

## Indications for use
The Aquamantys Double Cone Bipolar Sealer is a single use, sterile, bipolar device, intended to be used in conjunction with the Aquamantys 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/K101057
Methodology: https://510kreport.com/methodology