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510(k) K900069

MODIFIED PGL ABSORBABLE STAPLE* by United States Surgical, A Division of Tyco Healthc — Product Code GDG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1990
Date Received
January 4, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • 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 GDG

  • K891898 — SKIN HOOKS, VARIOUS TYPES (April 12, 1989)
  • K864425 — RAYLOR(TM) DISSECTING HOOK (December 12, 1986)
  • K843136 — BRIMFIELD CANNULATED GRASPING HOOKS (September 25, 1984)
  • K841010 — SURGICAL HOOKS, VARIOUS (May 1, 1984)
  • K812562 — SURGICAL RETRACTOR & ELASTIC STAYS, DISP (October 2, 1981)
  • K791120 — MIDDLE EAR PICKS, HOOKS CURETTES, (July 10, 1979)
  • K780289 — NERVE APPROXIMATER (June 14, 1978)
  • K771190 — ABRAMSON TRACHEA HOOK & RETRACTOR (July 11, 1977)
  • K771187 — DERMAHOOK #382-805 (July 11, 1977)