Home / 510(k) Clearances / K230746

510(k) K230746

Non absorbable Surgical Polypropylene Suture by Shandong Haidike Medical Products Co., Ltd. — Product Code GAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 2023
Date Received
March 17, 2023
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 Shandong Haidike Medical Products Co., Ltd.

  • K231183 — Non absorbable Surgical Polyester Suture (August 25, 2023)
  • K210518 — Surgical Face Mask (June 14, 2021)

Other clearances for product code GAW

  • K233355 — Cypris eXact Suturing System (January 12, 2024)
  • 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)
  • K173747 — REXLENE (December 21, 2018)
  • 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)