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510(k) K901719

KLEIN MICRO-CANNULA HANDLE(TM) by Jeff Klein Surgical, Inc. — Product Code GEA

K901719 is an FDA 510(k) premarket notification submitted by Jeff Klein Surgical, Inc. for the device "KLEIN MICRO-CANNULA HANDLE(TM)". The FDA issued a decision of Substantially Equivalent on May 22, 1990. The device falls under product code GEA (Cannula, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Jeff Klein Surgical, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 1990
Date Received
April 13, 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 Jeff Klein Surgical, Inc.

  • K901717 — KLEIN MICRO-CANNULA(TM) (May 24, 1990)
  • K901718 — KLEIN LAMPREY-CANNULA(TM) (May 24, 1990)
  • K901716 — KLEIN CONNECTOR(TM) (May 11, 1990)
  • K901715 — KLEIN CORK(TM) (May 11, 1990)

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