510(k) Report

FDA applicant

Salient Surgical Technologies, Inc.

Portsmouth, NH3 decisions2011–20111 recall

FDA records 3 decisions for Salient Surgical Technologies, Inc. (Portsmouth, NH) in 2011: 3 510(k) clearances. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 7 predicates, 0 of them its own earlier devices. 1 recall is linked to its devices.

FDA’s records also spell it “Salient Surgical Technologies”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Salient Surgical Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2011

2011: 3
2011high 3 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2013

2013: 1
2011high 1 (2013) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Salient Surgical Technologies, Inc. by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Salient Surgical Technologies, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories3decisions

Whose devices does it build on?

Its devices cite 7 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 8 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K111285Aquamantys 3 Pump Generator, Bipolar Sealer, Bipolar Sealer with CuttingSalient Surgical Technologies, Inc. · 20113cite it
  • K111732Aquamantys SBS 5.0 Sheated Biopolar SealerSalient Surgical Technologies, Inc. · 20113cite it
  • K101057Aquamantys Double Cone Bipolar Sealer Model: 23-310-1Salient Surgical Technologies · 20112cite it

What has FDA decided for it lately?

  • K111732Aquamantys SBS 5.0 Sheated Biopolar SealerSalient Surgical Technologies, Inc. · 2011
  • K111285Aquamantys 3 Pump Generator, Bipolar Sealer, Bipolar Sealer with CuttingSalient Surgical Technologies, Inc. · 20111 recall
  • K101057Aquamantys Double Cone Bipolar Sealer Model: 23-310-1Salient Surgical Technologies · 2011

All 2 as Salient Surgical Technologies, Inc. →The one decision as Salient Surgical Technologies →

What has been recalled?

1 recall linked to its devices; the latest:

  • K111285Medtronic Advanced Energy Aquamantys3 Pump Generator; Product Catalog Number: 10-1357…Nov 12, 2013Class II