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510(k) K982472

GENICON TROCAR by Genicon, LC — Product Code GEA

K982472 is an FDA 510(k) premarket notification submitted by Genicon, LC for the device "GENICON TROCAR". The FDA issued a decision of Substantially Equivalent on February 4, 1999. The device falls under product code GEA (Cannula, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Genicon, LC has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 4, 1999
Date Received
July 15, 1998
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 Genicon, LC

  • K030174 — GENICON LAPAROSCOPES (June 19, 2003)
  • K030269 — GENICON CLIP APPLIER (March 20, 2003)
  • K002542 — REUSABLE CANNULA (October 23, 2000)
  • K993625 — INSUFFLATION NEEDLE- 120MM, MODEL 900-200 (June 20, 2000)
  • K991382 — SHIELDEDTROCAR/CANNULA SYSTEM, MODEL 101-005-101 (July 15, 1999)

Other clearances for product code GEA

  • K003965 — MRI SAFE INSTRUMENTS (March 16, 2001)
  • K954599 — CONMED TROGARD ELECTRONIC TROCAR SYSTEM (November 27, 1995)
  • 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)
  • K901718 — KLEIN LAMPREY-CANNULA(TM) (May 24, 1990)
  • K901717 — KLEIN MICRO-CANNULA(TM) (May 24, 1990)

FDA data resources