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510(k) K000539

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

K000539 is an FDA 510(k) premarket notification submitted by Arc Medical Supplies (Beijing) Co, Ltd. for the device "NYLON NONABSORBABLE SURGICAL SUTURES, USP". The FDA issued a decision of SN on April 27, 2000. The device falls under product code GAR (Suture, Nonabsorbable, Synthetic, Polyamide), a Class II device regulated under 21 CFR 878.5020. 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, Polyamide
Device Class
Class II
Regulation Number
878.5020
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)
  • K000537 — POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP (April 27, 2000)

Other clearances for product code GAR

  • K261484 — Tissue Approximation System (June 3, 2026)
  • K220980 — Tissue Approximation System (TAS) (July 5, 2023)
  • K212888 — Golnit Nylon Monofilament Suture (March 31, 2022)
  • K212603 — Non Absorbable Surgical Nylon Suture (December 22, 2021)
  • K192420 — Crownjun Nylon Suture (May 29, 2020)
  • K161633 — REXLON, REXSIL (March 2, 2017)
  • K151165 — Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture (February 17, 2016)
  • K152795 — RiverLon (Nylon) Suture (October 28, 2015)
  • K123034 — VITAL SUTURES SUTUREX CIRUGIA PERUANA SUTUMED (May 28, 2013)
  • K081366 — KUMAR T-ANCHORS HERNIA SET (July 15, 2008)

FDA data resources