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510(k) K900487

MODIFIED AUTO SUTURE SURGIPORT TROCAR & SLEEVE by United States Surgical, A Division of Tyco Healthc — Product Code GDH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 1990
Date Received
January 23, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • 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 GDH

  • K903419 — MODIFIED SURGIPORT DISPOSABLE TROCAR AND SLEEVE (August 9, 1990)
  • K891901 — GOUGES, ALEXANDER, BISHOP, LUCAS (April 12, 1989)
  • K874879 — AUTO SUTURE(R) SURGIPORT DISPOS SURG TROCAR/SLEEVE (December 17, 1987)
  • K842822 — CHERMEL BONE GOUGES (August 2, 1984)
  • K760850 — PARKES HUMP GAUGE STRAIGHT 7 (18 CM) (November 3, 1976)