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510(k) K812388

SURGICAL PAWS by Berkeley Medevices — Product Code GDJ

K812388 is an FDA 510(k) premarket notification submitted by Berkeley Medevices for the device "SURGICAL PAWS". The FDA issued a decision of Substantially Equivalent on November 16, 1981. The device falls under product code GDJ (Clamp, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Berkeley Medevices has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1981
Date Received
August 20, 1981
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

Other clearances by Berkeley Medevices

  • K892220 — LAMINARIA TENT (June 14, 1989)
  • K840952 — MEDEVICE V-80 VACUUM PUMP (March 30, 1984)
  • K823006 — MEDEVICES ASPIRATION HOSE (November 4, 1982)
  • K812389 — SURGICAL LOOPS (November 16, 1981)

Other clearances for product code GDJ

  • K153358 — Standard Clamp (May 2, 2016)
  • 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)

FDA data resources