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510(k) K170842

WEGO-PTFE by Foosin Medical Supplies Inc., Ltd. — Product Code NBY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2017
Date Received
March 21, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene
Device Class
Class II
Regulation Number
878.5035
Review Panel
SU
Submission Type

Other clearances by Foosin Medical Supplies Inc., Ltd.

  • K201139 — WEGO-PDO Barbed Suture (October 20, 2020)
  • K193209 — Wego-Stainless Steel (February 19, 2020)
  • K183001 — WEGO-PGLA RAPID (January 28, 2019)
  • K183004 — WEGO-PGA RAPID (January 28, 2019)
  • 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 NBY

  • K231277 — TissueStat (November 9, 2023)
  • K192088 — GOLNIT Non-aborbable PTFE Surgical Suture (September 4, 2019)
  • K180992 — Biotex (July 16, 2019)
  • K191317 — StitchKit (July 12, 2019)
  • K181578 — DemeTECH PTFE Nonabsorbable Surgical Suture (October 11, 2018)
  • K180630 — PTFE SURGICAL SUTURE (April 6, 2018)
  • K173922 — C-PTFETM Surgical Suture (March 26, 2018)
  • K173335 — Gazelle PTFE and Suture Delivery Device (February 8, 2018)
  • K163049 — GOLNIT Non-Absorbable PTFE Surgical Suture (June 21, 2017)
  • K163639 — LS-5 ePTFE Suture (June 2, 2017)