# K123201: Aquamantys Endo DBS 8.7 Dissecting Bipolar Sealer

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Advanced Energy, LLC
- Decided: Jan 10, 2013 after 90 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: 5 generations back to K954171 (1996). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101057: Aquamantys Double Cone Bipolar Sealer Model: 23-310-1, Salient Surgical Technologies (2011) Summary page 1.

## Cited in the summary but kept off the family tree
- K010662: Modification to Tissuelink Monopolar Floating Ball, Tissuelink Medical, Inc. (2001). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The Aquamantys Endo DBS 8.7 Dissecting 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 at the operative site. It is intended for, but not limited to, abdominal, and thoracic surgery, endoscopic, laparoscopic, and thoracoscopic procedures. The device is not intended for contraceptive tubal coagulation (permanent female sterilization).

Source page: https://510kreport.com/device/K123201
Methodology: https://510kreport.com/methodology