Home / 510(k) Clearances / K183001

510(k) K183001

WEGO-PGLA RAPID by Foosin Medical Supplies Inc., Ltd. — Product Code GAM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 2019
Date Received
October 30, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Absorbable, Synthetic, Polyglycolic Acid
Device Class
Class II
Regulation Number
878.4493
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)
  • K183004 — WEGO-PGA 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)

Other clearances for product code GAM

  • K253852 — MONOCRYL™ Plus Antibacterial Poliglecaprone – 25 (Monofilament), Sterile Synthet (February 6, 2026)
  • K252743 — STRATAFIX™ Spiral PDS™ Plus Knotless Tissue Control Device; STRATAFIX™ Spiral MO (December 22, 2025)
  • K253620 — TroClose 1200 (December 16, 2025)
  • K252820 — PGLA90 Poly(glycolide-co-L-lactide) Surgical Sutures (Calypso); PGLA90 Poly(glyc (October 3, 2025)
  • K233265 — Monotime and Optime R (October 11, 2024)
  • K232372 — Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) (July 12, 2024)
  • K221527 — StitchKit (February 14, 2023)
  • K221744 — STRATAFIX™ Spiral MONOCRYL™ Plus Knotless Tissue Control Device (November 15, 2022)
  • K212810 — MONOFIX PGCL, knotless wound closure device (August 5, 2022)
  • K211792 — StitchKit (July 16, 2021)