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510(k) K201139

WEGO-PDO Barbed Suture by Foosin Medical Supplies Inc., Ltd. — Product Code NEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 2020
Date Received
April 28, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Surgical, Absorbable, Polydioxanone
Device Class
Class II
Regulation Number
878.4840
Review Panel
SU
Submission Type

Other clearances by Foosin Medical Supplies Inc., Ltd.

  • K193209 — Wego-Stainless Steel (February 19, 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)
  • K130737 — SYNTHETIC ABSORBABLE SUTURE (January 14, 2014)
  • K130735 — SYNTHETIC ABSORBABLE SUTURE (January 14, 2014)

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  • K240389 — Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread (March 27, 2024)
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