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510(k) K833377

MEDICALEX by Medicalex — Product Code GEA

K833377 is an FDA 510(k) premarket notification submitted by Medicalex for the device "MEDICALEX". The FDA issued a decision of Substantially Equivalent on September 27, 1984. The device falls under product code GEA (Cannula, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Medicalex has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1984
Date Received
September 29, 1983
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 Medicalex

  • K850946 — SURGICAL ASPIRATOR (September 16, 1985)
  • K851349 — LERE NAIL & PLATE COMBIN. ONE PIECE FORGED (May 29, 1985)
  • K831728 — MEDICALEX (January 9, 1984)

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)
  • K903416 — CANNULA, SURGICAL (November 23, 1990)
  • K904218 — SUCTION SYSTEM (October 31, 1990)
  • K901717 — KLEIN MICRO-CANNULA(TM) (May 24, 1990)

FDA data resources