510(k) Report

FDA applicant

Tissuelink Medical, Inc.

Dover, NH12 decisions2000–20084 recalls

FDA records 12 decisions for Tissuelink Medical, Inc. (Dover, NH) from 2000 to 2008: 12 510(k) clearances. All are in product code GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 7 predicates, 6 of them its own earlier devices. 4 recalls are linked to its devices.

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 Tissuelink Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2007: 12008: 1
2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Tissuelink Medical, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories12decisions

Whose devices does it build on?

Its devices cite 7 predicates; 6 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 22 times; 6 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.

  • K052859Aquamantys Pump Generator SystemTissuelink Medical, Inc. · 200510cite it
  • K063639Aquamantys SS4.0 Bipolar Sealer, Model 23-121-1Tissuelink Medical, Inc. · 20073cite it
  • K020574Tissuelink Bipolar Floating Ball DeviceTissuelink Medical, Inc. · 20022cite it
  • K032132Tissuelink Floating Ball Model 23-201-1Tissuelink Medical, Inc. · 20032cite it
  • K014260Tissuelink Solid Cylinder Monopolar DeviceTissuelink Medical, Inc. · 20022cite it
  • K073495Tissuelink Aquamantys Malleable Bipolar Sealer with LightTissuelink Medical, Inc. · 20081cites it

What has FDA decided for it lately?

  • K073495Tissuelink Aquamantys Malleable Bipolar Sealer with LightTissuelink Medical, Inc. · 2008
  • K063639Aquamantys SS4.0 Bipolar Sealer, Model 23-121-1Tissuelink Medical, Inc. · 2007
  • K052859Aquamantys Pump Generator SystemTissuelink Medical, Inc. · 20051 recall
  • K032132Tissuelink Floating Ball Model 23-201-1Tissuelink Medical, Inc. · 2003
  • K030380Tissuelink Sealing Forceps, Model 1 21-202-1Tissuelink Medical, Inc. · 2003
  • K022532Tissuelink Bipolar Floating Ball DeviceTissuelink Medical, Inc. · 20032 recalls
  • K020574Tissuelink Bipolar Floating Ball DeviceTissuelink Medical, Inc. · 20022 recalls
  • K014260Tissuelink Solid Cylinder Monopolar DeviceTissuelink Medical, Inc. · 20021 recall

All 12 as Tissuelink Medical, Inc. →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K052859Aquamantys 2.3 Bipolar Sealer Model #23-113-1. Product Usage: The Aquamantys Bipolar…Jul 18, 2011
  • K014260Tissuelink Dissecting Sealer DS3.5-C, Sterile Ref 13-121-1Feb 7, 2005
  • K020574ADP 3.2 Adapter, non sterile reusable Model Number: 30-801-1, an accessory used with the…Jul 22, 2004
  • K020574ADP2.1 Adapter, non-sterile reusable Model Number: 30-802-1 ,an accessory used with the…Jul 22, 2004