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510(k) K895579

POLYSORB SYNTHETIC ABSORBABLE SUTURE by United States Surgical, A Division of Tyco Healthc — Product Code GAN

K895579 is an FDA 510(k) premarket notification submitted by United States Surgical, A Division of Tyco Healthc for the device "POLYSORB SYNTHETIC ABSORBABLE SUTURE". The FDA issued a decision of SN on July 5, 1990. The device falls under product code GAN (Suture, Absorbable, Synthetic), a Class II device regulated under 21 CFR 878.4830. United States Surgical, A Division of Tyco Healthc has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
July 5, 1990
Date Received
September 15, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Absorbable, Synthetic
Device Class
Class II
Regulation Number
878.4830
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 GAN

  • K003015 — SSC'S PCL MONOFILAMENT SAS, VIOLET, COATED, MODEL TBD (December 15, 2000)
  • K964072 — MONOCRYL (POLIGLECAPRONE 25) SUTURE, UNDYED (December 18, 1996)
  • K960653 — MONOCRYL (POLIGLECAPRONE 25) SUTURE, DYED (MODIFIED) (March 28, 1996)
  • K951231 — ORTHOPEDIC PACKS (December 1, 1995)
  • K920978 — ULA (POLIGLECAPRONE 251) SYNTHETIC ABSOR SUT, DYED (February 15, 1994)
  • K900198 — DEXON II ABSORBABLE SURGICAL SUTURE, U.S.P. (July 5, 1990)

FDA data resources