510(k) Report

FDA applicant

Conmedcorp

Utica, NY92 decisions1981–201097 recalls

FDA records 92 decisions for Conmedcorp (Utica, NY) from 1981 to 2010: 92 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and GCJ (Laparoscope, General & Plastic Surgery). Its devices cite 7 predicates, 0 of them its own earlier devices. 97 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 Conmedcorp’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2022

2007: 12008: 342011: 112012: 182013: 22014: 12017: 12022: 1
2007high 34 (2008) · low 0 (2009)2026

Class I Class II/III not classified

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

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Which product codes does it file in?

  • GEIElectrosurgical, Cutting & Coagulation & Accessories43decisions
  • GCJLaparoscope, General & Plastic Surgery10decisions
  • GXYElectrode, Cutaneous6decisions
  • DRXElectrode, Electrocardiograph6decisions
  • CACApparatus, Autotransfusion3decisions
  • HETLaparoscope, Gynecologic (And Accessories)3decisions

Also: DSA (2), LKF (2), DRO (2), GCI (2), KMK (1), KPL (1).

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 39 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.

  • K990586Conmed Abc Probe for Flexible EndoscopesConmedcorp · 19994cite it
  • K020186Conmed System 5000 EsuConmedcorp · 20023cite it
  • K896626Hand Controlled Electrosurgical PencilsConmedcorp · 19902cite it
  • K973890Universalplus Laparoscopic Abc/Electrosurgical ElectrodeConmedcorp · 19982cite it
  • K955446Conmed Vcare Retractor/ElevatorConmedcorp · 19962cite it
  • K002002Surefit Dispersive ElectrodeConmedcorp · 20002cite it

What has FDA decided for it lately?

  • K101534Conmed Altrus Thermal Tissue Fusion SystemConmedcorp · 20108 recalls
  • K061021Entake Standard and Safety Peg SystemConmedcorp · 200628 recalls
  • K050992Conmed Irrigation NozzleConmedcorp · 2005
  • K050777Proforma HF 4.5 Cannula, Model 050906, 050907Conmedcorp · 2005
  • K050304FX Wire Advanced Measurement GuidewireConmedcorp · 2005
  • K041953Versastim, Perfoamax, Surgi-Stim, FaststartConmedcorp · 2004
  • K021079Abcsnare Electrosurgical Probe for Flexible Endoscopes, Model 1336XXConmedcorp · 2002
  • K021299Conmed Heatwave Hand-Controlled EletrodeConmedcorp · 2002

All 92 as Conmedcorp →

What has been recalled?

97 recalls linked to its devices; the latest:

  • K952204Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED…May 3, 2022Class II
  • K964844STAT 2 I.V. Gravity Flow Needle-Free Controller Primary Administration Sets and…Jun 19, 2017Class II
  • K101534Altrus Thermal Tissue Fusion Handpieces under the following specifications: 1) 10mm x 16…Feb 20, 2014Class II
  • K101534ALTRUS THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 36 cm Shaft, REF…Oct 23, 2013Class II
  • K101534ALTRUS THERMAL TISSUE FUSION, Tissue Fusion Handpiece, 5 mm O.D., 16 cm Shaft, REF…Oct 23, 2013Class II
  • K991855Goldvac (TM) UltraClean (R) Accessory Electrode 1 inch Coated Blade with Extended…Dec 27, 2012Class II