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510(k) K901107

MODIFIED AUTO SUTURE PURSTRING DISP. AUTOMATIC by United States Surgical, A Division of Tyco Healthc — Product Code GDJ

K901107 is an FDA 510(k) premarket notification submitted by United States Surgical, A Division of Tyco Healthc for the device "MODIFIED AUTO SUTURE PURSTRING DISP. AUTOMATIC". The FDA issued a decision of Substantially Equivalent on April 9, 1990. The device falls under product code GDJ (Clamp, Surgical, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800. United States Surgical, A Division of Tyco Healthc has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 1990
Date Received
March 8, 1990
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 United States Surgical, A Division of Tyco Healthc

  • K071406 — AUTOSUTURE ENDO CLIP III 5 MM CLIP APPLIER (November 21, 2007)
  • K071920 — AUTOSUTURE ABSORBABLE TACK AND APPLICATOR (September 28, 2007)
  • K061288 — AUTO SUTURE ENDO CLIP III 5 MM CLIP APPLIER (November 2, 2006)
  • K062850 — AUTOSUTURE CIRCULAR EEA SURGICAL STAPLERS (October 23, 2006)
  • K062326 — AUTOSUTURE MODIFIED VERSAPORT TROCAR WITH FIXATION SLEEVE (September 1, 2006)
  • K061095 — AUTO SUTUR ENDO GIA STAPLERS (May 31, 2006)
  • K050947 — MODIFICATION TO: MODIFIED USS POLYPROPYLENE SUTURE (June 1, 2005)
  • K042412 — MODIFIED SPACEMAKER SYSTEM (September 24, 2004)
  • K040594 — HERCULON SOFT TISSUE REATTACHMENT SYSTEM (March 31, 2004)
  • K032696 — AUTO SUTURE ENDOSCOPIC (& OPEN) TA SURGICAL STAPLER, AUTO SUTURE ENDOSCOPIC (& O (December 1, 2003)

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)
  • 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)

FDA data resources