# K052859: Aquamantys Pump Generator System

- Pathway: 510(k) (Special)
- Applicant: Tissuelink Medical, Inc.
- Decided: Oct 25, 2005 after 14 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: 3 generations back to K954171 (1996). 6 ancestors in all.
24 later devices descend from it; 10 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024059: MBC Series, Soring GmbH Medizintechnik (2003) Summary page 1.
- K020574: Tissuelink Bipolar Floating Ball Device, Tissuelink Medical, Inc. (2002)
- K022532: Tissuelink Bipolar Floating Ball Device, Tissuelink Medical, Inc. (2003) Summary page 1.
- K032132: Tissuelink Floating Ball Model 23-201-1, Tissuelink Medical, Inc. (2003) Summary page 1.

## Most influential descendants
- K063639: Aquamantys SS4.0 Bipolar Sealer, Model 23-121-1 (2007), 7 descendants of its own
- 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
- K130110: Meddusa Bipolar System (2013), 4 descendants of its own
- K190336: Soniquence Bipolar Electrodes (2019), 3 descendants of its own

## Recalls of this device
- Jul 18, 2011 · Not classified · Z-2892-2011: Insulating material on the shaft of the device may separate and expose the electrical conductor and result in burning the patient skin

## Indications for use
The Aquamantys™ Bipolar Pump Generator is an electrosurgical generator with a rotary peristaltic pump which is for use only with Aquamantys single-use disposable bipolar devices for concurrent delivery of radiofrequency energy with saline for hemostatic sealing of soft tissue and bone at the operative site. It is intended for, but not limited to, endoscopic and open abdominal, orthopaedic, spine and thoracic surgery. The device is not intended for contraceptive tubal coagulation (permanent female sterilization). The Aquamantys System is for use only by qualified medical personnel properly trained in the use of electrosurgical equipment, technology and techniques.

Source page: https://510kreport.com/device/K052859
Methodology: https://510kreport.com/methodology