AQUAMANTYS 3 PUMP GENERATOR, BIPOLAR SEALER, BIPOLAR SEALER WITH CUTTING— 510(k) K111285

Clearance details

Applicant

Salient Surgical Technologies, Inc.

Product code

Code GEI

Device class

Class 2

Regulation

21 CFR 878.4400

Advisory panel

General, Plastic Surgery

Date received

2011-05-06

Decision date

2011-09-09

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Portsmouth, NH, US

• K254185 — Potenza Prime2026-09-11
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• K253859 — Scarlet Pro (Scarlet Pro)2026-08-27
• K252535 — Inno-Switch Laparoscopic Instruments2026-08-25
• K261179 — AlphaTriPart - Monopolar MIC Instruments2026-07-22

• K111732 — AQUAMANTYS SBS 5.0 SHEATED BIOPOLAR SEALER2011-12-05

Death

133

Injury

7,585

Malfunction

35,808

Other

44

Total

43,570

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0905-2014 — Medtronic Advanced Energy Aquamantys3 Pump Generator; Product Catalog Number: 10-1357 (Generator assembly), 40-404-1(as shipped, including accessories) The Aquamantys3 System combines radio frequency (RF) energy and saline to reduce blood loss during and after surgical procedures. This patented Transcollation technology has been shown to reduce transfusion rates and may also reduce the need for other blood management procedures.Class II·Terminated·Medtronic Advanced Energy, LLC·20131112

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111285.