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510(k) K153358

Standard Clamp by Standard Bariatrics — Product Code GDJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2016
Date Received
November 20, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Surgical, General & Plastic Surgery
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

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  • K170379 — Disposable Standard Clamp (July 19, 2017)

Other clearances for product code GDJ

  • K930315 — THORACIC CLAMPS: SAROT, KANTOWITZ AND LAWRENCE (February 4, 1994)
  • K924223 — MAR-MED LIVER STRAP (March 18, 1993)
  • K922659 — GENERAL SURGERY CLAMP AND NEEDLE HOLDER (July 21, 1992)
  • K914913 — GRICE FOOT PEDAL CONTROL/REDDICK IRRI/ASPIR SYST (December 31, 1991)
  • K900956 — GS-7100 CHOLANGIOGRAM CLAMP, 5MM (April 18, 1990)
  • K901107 — MODIFIED AUTO SUTURE PURSTRING DISP. AUTOMATIC (April 9, 1990)
  • K895726 — VESSEL OCCLUDER (October 24, 1989)
  • K895591 — SILICONE INSTRUMENT SHODS (October 20, 1989)
  • K882169 — SURGICAL DUCT CLAMP (VINE) (June 17, 1988)
  • K881741 — STUART LEE CLIP (June 3, 1988)