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510(k) K903416

CANNULA, SURGICAL by Advantage Diagnostics Corp. — Product Code GEA

K903416 is an FDA 510(k) premarket notification submitted by Advantage Diagnostics Corp. for the device "CANNULA, SURGICAL". The FDA issued a decision of Substantially Equivalent on November 23, 1990. The device falls under product code GEA (Cannula, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Advantage Diagnostics Corp. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 1990
Date Received
July 30, 1990
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 Advantage Diagnostics Corp.

  • K023712 — ADVANTAGE MULTIPLE DRUGS OF ABUSE TEST (January 31, 2003)
  • K013778 — PEACE OF MIND HOME DRUG TEST (February 7, 2002)
  • K011962 — ADVANTAGE MARIJUANA (THC) AND COCAINE HOME DRUG TEST (August 9, 2001)
  • K010921 — ADVANTAGE MARIJUANA (THC) HOME DRUG TEST (June 25, 2001)
  • K003708 — ADVANTAGE THC/COCAINE TEST (January 22, 2001)
  • K001567 — ADVANTAGE THC TEST (June 19, 2000)
  • K994227 — ADVANTAGE HCG TEST (URINE/SERUM) (February 3, 2000)
  • K991883 — REDI-TEST OPIATES (September 15, 1999)
  • K881369 — ADVANCE DIAGNOSTICS DISPOSABLE EYECUP (May 13, 1988)

Other clearances for product code GEA

  • K003965 — MRI SAFE INSTRUMENTS (March 16, 2001)
  • K982472 — GENICON TROCAR (February 4, 1999)
  • 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)
  • 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