510(k) Report

FDA applicant

Vidamed, Inc.

Menlo Park, CA11 decisions1995–20020 recalls

FDA records 11 decisions for Vidamed, Inc. (Menlo Park, CA) from 1995 to 2002: 11 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and KNS (Unit, Electrosurgical, Endoscopic (With Or…). Its devices cite 7 predicates, 7 of them its own earlier devices. No recall is 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 Vidamed, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Vidamed, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Vidamed, 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 & Accessories7decisions
  • KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)4decisions

Who builds on its devices?

Later devices cite its devices 21 times; 7 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.

  • K960918Vidamed Tuna (Transurethral Needle Ablation) SystemVidamed, Inc. · 19965cite it
  • K002583Tuna (Trans Urethra Needle) Office SystemVidamed, Inc. · 20014cite it
  • K951245Vidamed 50 Electrosurgical Generator, Vidamed Aec (Adjustable Electrosurgical Cartridge) AccessoryVidamed, Inc. · 19953cite it
  • K014224Precision Plus Tuna Office SystemVidamed, Inc. · 20022cite it
  • K965061Vidamed Modedl 7600 RF GeneratorVidamed, Inc. · 19972cite it
  • K955035Vidamed Series 7205 Electrosurgical GeneratorVidamed, Inc. · 19952cite it

What has FDA decided for it lately?

  • K014224Precision Plus Tuna Office SystemVidamed, Inc. · 2002
  • K012587RF Generators, Disposable Cartridge Kit, Disposable Cartridge, Reusable Handle, Disoisable Handpiece…Vidamed, Inc. · 2001
  • K011787Precision Tuna Office System with NO Rectal Temperature Monitoring TapeVidamed, Inc. · 2001
  • K002583Tuna (Trans Urethra Needle) Office SystemVidamed, Inc. · 2001
  • K973366Cobra Hand PieceVidamed, Inc. · 1997
  • K965199Tuna 5 CatheterVidamed, Inc. · 1997
  • K965061Vidamed Modedl 7600 RF GeneratorVidamed, Inc. · 1997
  • K963180Vidamed RF Generator Data RecorderVidamed, Inc. · 1996

All 11 as Vidamed, Inc. →