# K211203: Green OR Reprocessed Aquamantys Bipolar Sealer

- Pathway: 510(k) (Traditional)
- Applicant: Green Or, LLC
- Decided: Apr 7, 2022 after 350 days
- Product code: NUJ (Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed)
- 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: 7 generations back to K954171 (1996). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132974: Aquamantys 2.3 Bipolar Sealer, Evs 4.0 Epidural Vein Sealer, Mini Evs 3.4 Epidural Vein Sealer, SBS 5.0 Sheathed Bipolar, Medtronic Advanced Energy, LLC (2013) Summary page 5.
- K120537: AQUAMANTYS3 9.5 XL Bipolar Sealer, Medtronic, Inc. (2012) Summary page 5.
- K111285: Aquamantys 3 Pump Generator, Bipolar Sealer, Bipolar Sealer with Cutting, Salient Surgical Technologies, Inc. (2011) Summary page 5.

## Indications for use
The Green OR Reprocessed Aquamantys Bipolar Sealer is a sterile, single-use bipolar electrosurgical device intended to be used in conjunction with a qualified Pump Generator for delivery of radio-frequency (RF) energy and saline for hemostatic sealing and coagulation of soft tissue and bone at the operative site. The device is not intended for contraceptive tubal coagulation (permanent female sterilization). The Green OR Reprocessed Aquamantys 2.3 Bipolar Sealer is intended for, but not limited to orthopaedic, neurosurgical, spine, thoracic, and open abdominal surgery. The Green OR Reprocessed Aquamantys 6.0 Bipolar Sealer is intended for, but not limited to orthopaedic, spine, thoracic, and open abdominal surgery. The Green OR Reprocessed Aquamantys 9.5 XL Bipolar Sealer is intended for, but not limited to open abdominal, orthopaedic, and thoracic surgery.

Source page: https://510kreport.com/device/K211203
Methodology: https://510kreport.com/methodology