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510(k) K901303

HORIZON SURGICAL LIGATING AND MARKING CLIP by Horizon Surgical, Inc. — Product Code DSS

K901303 is an FDA 510(k) premarket notification submitted by Horizon Surgical, Inc. for the device "HORIZON SURGICAL LIGATING AND MARKING CLIP". The FDA issued a decision of Substantially Equivalent on June 5, 1990. The device falls under product code DSS (Clip, Vascular), a Class II device regulated under 21 CFR 870.3250.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 1990
Date Received
March 20, 1990
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 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)
  • K883909 — SURGICAL SPRING CLIPS (December 27, 1988)
  • K771021 — AUTO-CLIP (June 14, 1977)

FDA data resources