# K063639: Aquamantys SS4.0 Bipolar Sealer, Model 23-121-1

- Pathway: 510(k) (Traditional)
- Applicant: Tissuelink Medical, Inc.
- Decided: Feb 22, 2007 after 77 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.
7 later devices descend from it; 3 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)
- K052859: Aquamantys Pump Generator System, Tissuelink Medical, Inc. (2005) Summary page 1.

## Most influential descendants
- K111732: Aquamantys SBS 5.0 Sheated Biopolar Sealer (2011), 5 descendants of its own
- K132974: Aquamantys 2.3 Bipolar Sealer, Evs 4.0 Epidural Vein Sealer, Mini Evs 3.4 Epidural Vein Sealer, SBS 5.0 Sheathed Bipolar (2013), 4 descendants of its own
- 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

## Indications for use
The TissueLink SS4.0 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 site. It is intended for but not limited to orthopaedic, spine, endoscopic procedures, ad¢ginatand thoraditmf1ery, anjf aqpidqurlm neitllkr dqring s'.rgy. The device is not intended for contraceptive tubal coagulation Qpermanent emale sterilization.)

Source page: https://510kreport.com/device/K063639
Methodology: https://510kreport.com/methodology