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510(k) K771021

AUTO-CLIP by Axiom Medical, Inc. — Product Code DSS

K771021 is an FDA 510(k) premarket notification submitted by Axiom Medical, Inc. for the device "AUTO-CLIP". The FDA issued a decision of Substantially Equivalent on June 14, 1977. The device falls under product code DSS (Clip, Vascular), a Class II device regulated under 21 CFR 870.3250. Axiom Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 14, 1977
Date Received
June 6, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clip, Vascular
Device Class
Class II
Regulation Number
870.3250
Review Panel
CV
Submission Type

Other clearances by Axiom Medical, Inc.

  • K993592 — AXIOM MULTIPURPOSE WOUND DRAIN (May 17, 2000)
  • K971851 — INTERPLEURAL ANESTHESIA CATHETER (January 22, 1998)
  • K965146 — FLAT CLOSED WOUND DRAIN WITH TROCAR (March 10, 1997)
  • K934895 — GLASSMAN SILICONE CATHETER (October 13, 1994)
  • K922760 — ATRAUM WOUND DRESSING--MODIFICATION (October 30, 1992)
  • K905422 — PVC ROUND WOUND DRAINS (February 11, 1991)
  • K904218 — SUCTION SYSTEM (October 31, 1990)
  • K904133 — DISPOSABLE FLUID COLLECTION BAG (October 11, 1990)
  • K863247 — AXIOM TROCAR THORACIC CATHETER (August 29, 1986)
  • K861306 — SUCTION SYSTEM (June 9, 1986)

Other clearances for product code DSS

  • K983744 — MCAS (MODULAR CLIP APPLIER SYSTEM) (January 21, 1999)
  • K961333 — HEARTPORT MULTIFIRE CLIP APPLIER (November 15, 1996)
  • K920104 — IDENTI LOOPS DEGANIA SILICONE (April 20, 1992)
  • K920676 — RMI SOFCLAMP (April 15, 1992)
  • K914523 — CRI VESSEL OCCLUSIN SYSTEM/CRI OCCLUSION COIL (January 10, 1992)
  • K901303 — HORIZON SURGICAL LIGATING AND MARKING CLIP (June 5, 1990)
  • K883909 — SURGICAL SPRING CLIPS (December 27, 1988)

FDA data resources