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510(k) K945978

TUBING, NONINVASIVE by Endoscopic Technologies, Inc. — Product Code GAZ

K945978 is an FDA 510(k) premarket notification submitted by Endoscopic Technologies, Inc. for the device "TUBING, NONINVASIVE". The FDA issued a decision of Substantially Equivalent on January 11, 1995. The device falls under product code GAZ (Tubing, Noninvasive), a Class II device regulated under 21 CFR 880.6740. Endoscopic Technologies, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 1995
Date Received
December 8, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubing, Noninvasive
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type

Other clearances by Endoscopic Technologies, Inc.

  • K060101 — ESTECH AORTIC EASY FLOW CANNULA (May 10, 2006)
  • K053326 — ESTECH COBRA ELECTROSURGICAL UNIT & CABLE (January 6, 2006)
  • K053100 — ESTECH COBRA BIPOLAR SYSTEM (December 19, 2005)
  • K946105 — ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES (April 6, 1995)
  • K945979 — TROCAR/CANNULA (December 21, 1994)
  • K924057 — DISPOSIBLE ELECTRO COAGULATION PROBE (March 11, 1994)
  • K922685 — TROCARS (April 5, 1993)

Other clearances for product code GAZ

  • K952605 — SUCTION/IRRIGATOR TUBING KIT (September 15, 1995)
  • K930512 — SUCTION/IRRIGATION Y TUBING SET W/TRUMPET VALVES (July 23, 1993)
  • K911865 — NORTEC CONNECTING TUBE SET (November 1, 1991)
  • K910471 — MEDID-VAC CLEAR NONCONDUCTIVE CONNECTING TUBE (March 8, 1991)
  • K910170 — MAXI-FLOW SUCTION SET 12 FT. (February 1, 1991)
  • K910171 — MAXI-FLOW SUCTION SET W/Y CONNECTOR (February 1, 1991)
  • K882315 — VIR-A-VAC EMPTY (September 26, 1988)
  • K883473 — SURGICAL CONNECTING TUBES (August 25, 1988)
  • K864964 — 5 - IN - 1 CONNECTOR (January 20, 1987)
  • K861757 — 5 IN 1 CONNECTOR (June 6, 1986)

FDA data resources