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510(k) K043330

POLYPROPILENE SURGICAL SUTURES by Demetech Corp. — Product Code GAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 16, 2005
Date Received
December 2, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polypropylene
Device Class
Class II
Regulation Number
878.5010
Review Panel
SU
Submission Type

Other clearances by Demetech Corp.

  • K141007 — DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE (September 25, 2014)
  • K123940 — DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE (May 30, 2014)
  • K130083 — DEMECAPRONE (POLIGLECAPRONE 25) SYNTHETIC MONOFILAMENT (PGCL) ABSORBABLE SUTURE (July 17, 2013)
  • K082097 — DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE (January 8, 2010)
  • K072930 — DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT (April 30, 2008)
  • K043539 — DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLES (April 6, 2005)
  • K033550 — DXL CALSCAN (May 5, 2004)
  • K023028 — DEMETECH NYLON NONABSORBABLE SUTURE (June 18, 2003)
  • K023030 — DEMETECH POLYESTER NONABSORBABLE SUTURE (June 18, 2003)
  • K023029 — DEMETECH SILK NONABSORBABLE SUTURE (November 25, 2002)

Other clearances for product code GAW

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  • K230746 — Non absorbable Surgical Polypropylene Suture (September 14, 2023)
  • K221280 — Vesseal (December 9, 2022)
  • K211178 — DURAMESH Mesh Suture (September 2, 2022)
  • K192953 — APTOS Threads – Polypropylene Surgical Sutures (August 27, 2020)
  • K193530 — Deklene MAXX (March 19, 2020)
  • K191299 — Silhouette Featherlift / Silhouette Lift (June 14, 2019)
  • K173747 — REXLENE (December 21, 2018)
  • K180321 — Aesculap Optilene Nonabsorbable Suture (March 7, 2018)
  • K173644 — Gazelle Polypropylene Suture and Delivery Device (February 15, 2018)