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510(k) K023029

DEMETECH SILK NONABSORBABLE SUTURE by Demetech Corp. — Product Code GAP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 2002
Date Received
September 11, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Silk
Device Class
Class II
Regulation Number
878.5030
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)
  • K043330 — POLYPROPILENE SURGICAL SUTURES (May 16, 2005)
  • K043539 — DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLES (April 6, 2005)
  • K033550 — DXL CALSCAN (May 5, 2004)
  • K023030 — DEMETECH POLYESTER NONABSORBABLE SUTURE (June 18, 2003)
  • K023028 — DEMETECH NYLON NONABSORBABLE SUTURE (June 18, 2003)

Other clearances for product code GAP

  • K241486 — Sofsilk™ Coated Braided Silk Suture (December 3, 2024)
  • K222944 — SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Sutur (October 18, 2024)
  • K232355 — Non absorbable Surgical Silk Suture (January 16, 2024)
  • K221767 — Surgical Sutures with or without Needle (July 31, 2023)
  • K180701 — SafePath Suturing System (June 25, 2018)
  • K172149 — FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbabl (October 20, 2017)
  • K162396 — SILK Surgical Suture (November 23, 2016)
  • K160623 — FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbabl (May 31, 2016)
  • K080684 — WG-SURGICAL SUTURES WITH NEEDLE (June 9, 2008)
  • K071111 — NON-ABSORBABLE SILK SUTURE (July 17, 2007)