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510(k) K141007

DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE by Demetech Corp. — Product Code GAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 2014
Date Received
April 18, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile
Device Class
Class II
Regulation Number
878.4495
Review Panel
SU
Submission Type

Other clearances by Demetech Corp.

  • 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)
  • K023028 — DEMETECH NYLON NONABSORBABLE SUTURE (June 18, 2003)
  • K023030 — DEMETECH POLYESTER NONABSORBABLE SUTURE (June 18, 2003)
  • K023029 — DEMETECH SILK NONABSORBABLE SUTURE (November 25, 2002)

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  • K172146 — MERISTEEL (February 1, 2018)
  • K170767 — Surgical Stainless Steel Suture, Stainless Steel Suture (November 1, 2017)
  • K140127 — FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP (May 28, 2014)
  • K081060 — FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5 (December 24, 2008)
  • K082828 — SUTURTEK 360 DEGREE STERNAL CLOSURE DEVICE (October 14, 2008)
  • K063603 — SUTURTEK SURGICAL STEEL SUTURE, MODELS SC-S13, SC-S14, SC-S15, SC-S16, SC-S17 (February 7, 2007)
  • K042606 — MODIFICATION TO:SYNTHES (USA) TITANIUM WIRE (May 27, 2005)
  • K041333 — SYNTHES (USA) TITANIUM WIRE (August 27, 2004)