# K073495: Tissuelink Aquamantys Malleable Bipolar Sealer with Light

- Pathway: 510(k) (Special)
- Applicant: Tissuelink Medical, Inc.
- Decided: Jan 9, 2008 after 28 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). 7 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 10 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.

## Most influential descendants
- K181071: SIRA RFA Electrosurgical Device (2019), 1 descendant of its own
- K232947: SIRA™ RFA Electrosurgical Device (2023), 0 descendants of its own

## Indications for use
The Aquamantys single-use disposable Malleable Bipolar Sealer with Light is a sterile, 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 site. 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/K073495
Methodology: https://510kreport.com/methodology