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510(k) K895591

SILICONE INSTRUMENT SHODS by Key Surgical, Inc. — Product Code GDJ

K895591 is an FDA 510(k) premarket notification submitted by Key Surgical, Inc. for the device "SILICONE INSTRUMENT SHODS". The FDA issued a decision of Substantially Equivalent on October 20, 1989. The device falls under product code GDJ (Clamp, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. Key Surgical, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 1989
Date Received
September 15, 1989
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 Key Surgical, Inc.

  • K150532 — Universal Light Handle Cover, Light Handle Cover (September 22, 2015)
  • K151222 — Cautery Tip Cleaner (May 22, 2015)
  • K910328 — KEY COMFORT GRIPS (March 6, 1991)
  • K896676 — KEY VASCULAR LOOPS (February 27, 1990)
  • K896472 — KEY VASCULAR BOOTIES (December 14, 1989)

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)
  • K882169 — SURGICAL DUCT CLAMP (VINE) (June 17, 1988)
  • K881741 — STUART LEE CLIP (June 3, 1988)

FDA data resources