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510(k) K954599

CONMED TROGARD ELECTRONIC TROCAR SYSTEM by Conmedcorp — Product Code GEA

K954599 is an FDA 510(k) premarket notification submitted by Conmedcorp for the device "CONMED TROGARD ELECTRONIC TROCAR SYSTEM". The FDA issued a decision of Substantially Equivalent on November 27, 1995. The device falls under product code GEA (Cannula, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Conmedcorp has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 27, 1995
Date Received
October 3, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Surgical, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

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)
  • K050304 — FX WIRE ADVANCED MEASUREMENT GUIDEWIRE (March 8, 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)

Other clearances for product code GEA

  • K003965 — MRI SAFE INSTRUMENTS (March 16, 2001)
  • K982472 — GENICON TROCAR (February 4, 1999)
  • K922460 — ORIGIN SECONDARY CANNULA AND TROCAR (September 16, 1992)
  • K920110 — ENDOPATH DISPOSABLE THORACIC TROCAR SLEEVE (April 2, 1992)
  • K911262 — DISPOSABLE SPECIMEN BAG W/CANNULA AND INTRODUCER (June 20, 1991)
  • K904881 — DISPOSABLE YANKAUER SUCTION TUBE (March 6, 1991)
  • K903416 — CANNULA, SURGICAL (November 23, 1990)
  • K904218 — SUCTION SYSTEM (October 31, 1990)
  • K901717 — KLEIN MICRO-CANNULA(TM) (May 24, 1990)
  • K901718 — KLEIN LAMPREY-CANNULA(TM) (May 24, 1990)

FDA data resources