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510(k) K193209

Wego-Stainless Steel by Foosin Medical Supplies Inc., Ltd. — Product Code GAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 2020
Date Received
November 21, 2019
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 Foosin Medical Supplies Inc., Ltd.

  • K201139 — WEGO-PDO Barbed Suture (October 20, 2020)
  • K183004 — WEGO-PGA RAPID (January 28, 2019)
  • K183001 — WEGO-PGLA RAPID (January 28, 2019)
  • K170842 — WEGO-PTFE (July 31, 2017)
  • K142810 — WEGO-PGCL Absorbable Surgical Monofilament Suture (November 14, 2014)
  • K130735 — SYNTHETIC ABSORBABLE SUTURE (January 14, 2014)
  • K130737 — SYNTHETIC ABSORBABLE SUTURE (January 14, 2014)

Other clearances for product code GAQ

  • K203855 — CoNextions TR Tendon Repair System (April 22, 2022)
  • K172146 — MERISTEEL (February 1, 2018)
  • K170767 — Surgical Stainless Steel Suture, Stainless Steel Suture (November 1, 2017)
  • K141007 — DEMESTEEL (STAINLESS STEEL) NON-ABSORBABLE SUTURE (September 25, 2014)
  • 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)