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510(k) K000537

POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP by Arc Medical Supplies (Beijing) Co, Ltd. — Product Code GAW

K000537 is an FDA 510(k) premarket notification submitted by Arc Medical Supplies (Beijing) Co, Ltd. for the device "POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP". The FDA issued a decision of SN on April 27, 2000. The device falls under product code GAW (Suture, Nonabsorbable, Synthetic, Polypropylene), a Class II device regulated under 21 CFR 878.5010. Arc Medical Supplies (Beijing) Co, Ltd. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
April 27, 2000
Date Received
February 17, 2000
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 Arc Medical Supplies (Beijing) Co, Ltd.

  • K022666 — PDO (POLYDIOXANONE) MONOFILAMENT SYNTHETIC ABSORBABLE SUTURE U.S.P. (October 9, 2002)
  • K022664 — PGA (POLYGLYCOLIC) SYNTHETIC ABSORBABLE SUTURE U.S.P. (September 10, 2002)
  • K000542 — PLAIN AND CHRONIC GUT ABSORBABLE SURGICAL SUTURES, USP (April 28, 2000)
  • K000541 — SILK NONABSORBABLE SURGICAL SUTURES, USP (April 28, 2000)
  • K000540 — POLYESTER NONABSORBABLE SURGICAL SUTURES, USP (April 27, 2000)
  • K000539 — NYLON NONABSORBABLE SURGICAL SUTURES, USP (April 27, 2000)

Other clearances for product code GAW

  • K253572 — STRATAFIX™ Spiral PRONOVA™ Unidirectional Knotless Tissue Control Device STRATA (March 27, 2026)
  • 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)
  • K173747 — REXLENE (December 21, 2018)
  • K180321 — Aesculap Optilene Nonabsorbable Suture (March 7, 2018)

FDA data resources