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510(k) K900069

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

K900069 is an FDA 510(k) premarket notification submitted by United States Surgical, A Division of Tyco Healthc for the device "MODIFIED PGL ABSORBABLE STAPLE*". The FDA issued a decision of Substantially Equivalent on April 16, 1990. The device falls under product code GDG (Hook, 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 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

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 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)
  • K771187 — DERMAHOOK #382-805 (July 11, 1977)
  • K771190 — ABRAMSON TRACHEA HOOK & RETRACTOR (July 11, 1977)

FDA data resources