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510(k) K050304

FX WIRE ADVANCED MEASUREMENT GUIDEWIRE by Conmedcorp — Product Code OCY

K050304 is an FDA 510(k) premarket notification submitted by Conmedcorp for the device "FX WIRE ADVANCED MEASUREMENT GUIDEWIRE". The FDA issued a decision of Substantially Equivalent on March 8, 2005. The device falls under product code OCY (Endoscopic Guidewire, Gastroenterology-Urology), a Class II device regulated under 21 CFR 876.1500. Conmedcorp has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 8, 2005
Date Received
February 8, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Endoscopic Guidewire, Gastroenterology-Urology
Device Class
Class II
Regulation Number
876.1500
Review Panel
GU
Submission Type

To provide access to gi or gu tract for the purpose of passing or exchanging other accessories.

Other clearances by Conmedcorp

  • K101534 — CONMED ALTRUS THERMAL TISSUE FUSION SYSTEM (November 24, 2010)
  • K061021 — ENTAKE STANDARD AND SAFETY PEG SYSTEM (April 28, 2006)
  • K050992 — CONMED IRRIGATION NOZZLE (July 14, 2005)
  • K050777 — PROFORMA HF 4.5 CANNULA, MODEL 050906, 050907 (April 22, 2005)
  • K041953 — VERSASTIM, PERFOAMAX, SURGI-STIM, FASTSTART (August 9, 2004)
  • K021079 — ABCSNARE ELECTROSURGICAL PROBE FOR FLEXIBLE ENDOSCOPES, MODEL 1336XX (July 1, 2002)
  • K021299 — CONMED HEATWAVE HAND-CONTROLLED ELETRODE (June 26, 2002)
  • K020186 — CONMED SYSTEM 5000 ESU (April 12, 2002)
  • K020135 — CONMED SYSTEM 2000 ELECTROSURGICAL GENERATOR, REF: 60-8002; CONMED ESU CART, REF (April 12, 2002)
  • K002002 — SUREFIT DISPERSIVE ELECTRODE (August 17, 2000)

Other clearances for product code OCY

  • K153264 — EasyPass Guidewire (May 19, 2016)
  • K151471 — Radifocus Glidewire Endoscopic Wire (September 17, 2015)
  • K150927 — Orchestra Hydrophilic Guidewire standard angled, Orchestra Hydrophilic Guidewire (May 27, 2015)
  • K150225 — NovaGold High Performance Guidewire (March 16, 2015)
  • K142950 — Acrobat Calibrated Tip Wire Guide (November 5, 2014)
  • K141820 — JAGWIRE HIGH PERFORMANCE GUIDWIRE (October 21, 2014)
  • K142397 — Predicate III Guidewire (September 19, 2014)
  • K140482 — MANDREL GUIDEWIRE (April 8, 2014)
  • K133076 — NOVAGOLD HIGH PERFORMANCE GUIDEWIRE (February 20, 2014)
  • K131072 — ORCHESTRA HYDROPHILIC GUIDEWIRE STANDARD ANGLED, ORCHESTRA HYDROPHILIC GUIDEWIRE (July 9, 2013)

FDA data resources