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510(k) K024275

AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER by United States Surgical, A Division of Tyco Healthc — Product Code GDW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2003
Date Received
December 23, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Staple, Implantable
Device Class
Class II
Regulation Number
878.4750
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)

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