Home / 510(k) Clearances / K843816

510(k) K843816

TAL-CLIP by Talboy, Inc. — Product Code GDJ

K843816 is an FDA 510(k) premarket notification submitted by Talboy, Inc. for the device "TAL-CLIP". The FDA issued a decision of Substantially Equivalent on October 31, 1984. The device falls under product code GDJ (Clamp, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 31, 1984
Date Received
September 28, 1984
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 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