Home / 510(k) Clearances / K173747

510(k) K173747

REXLENE by Sm Eng Co., Ltd. — Product Code GAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2018
Date Received
December 8, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Synthetic, Polypropylene
Device Class
Class II
Regulation Number
878.5010
Review Panel
SU
Submission Type

Other clearances by Sm Eng Co., Ltd.

  • K200392 — REXSIN (July 7, 2020)
  • K173779 — REXMONO, PDREX (March 12, 2018)
  • K161633 — REXLON, REXSIL (March 2, 2017)
  • K161629 — CRYLREX (February 10, 2017)

Other clearances for product code GAW

  • K233355 — Cypris eXact Suturing System (January 12, 2024)
  • K230746 — Non absorbable Surgical Polypropylene Suture (September 14, 2023)
  • K221280 — Vesseal (December 9, 2022)
  • K211178 — DURAMESH Mesh Suture (September 2, 2022)
  • K192953 — APTOS Threads – Polypropylene Surgical Sutures (August 27, 2020)
  • K193530 — Deklene MAXX (March 19, 2020)
  • K191299 — Silhouette Featherlift / Silhouette Lift (June 14, 2019)
  • K180321 — Aesculap Optilene Nonabsorbable Suture (March 7, 2018)
  • K173644 — Gazelle Polypropylene Suture and Delivery Device (February 15, 2018)
  • K171039 — Assut Filbloc Permanent Sutures (August 29, 2017)