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510(k) K000541

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

K000541 is an FDA 510(k) premarket notification submitted by Arc Medical Supplies (Beijing) Co, Ltd. for the device "SILK NONABSORBABLE SURGICAL SUTURES, USP". The FDA issued a decision of Substantially Equivalent on April 28, 2000. The device falls under product code GAP (Suture, Nonabsorbable, Silk), a Class II device regulated under 21 CFR 878.5030. Arc Medical Supplies (Beijing) Co, Ltd. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2000
Date Received
February 17, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Nonabsorbable, Silk
Device Class
Class II
Regulation Number
878.5030
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)
  • K000540 — POLYESTER NONABSORBABLE SURGICAL SUTURES, USP (April 27, 2000)
  • K000539 — NYLON NONABSORBABLE SURGICAL SUTURES, USP (April 27, 2000)
  • K000537 — POLYPROPYLENE NONABSORBABLE SURGICAL SUTURES, USP (April 27, 2000)

Other clearances for product code GAP

  • K241486 — Sofsilk™ Coated Braided Silk Suture (December 3, 2024)
  • K222944 — SafePath Sulturing System-Silk Suture, SafePath Sulturing System Polyamide Sutur (October 18, 2024)
  • K232355 — Non absorbable Surgical Silk Suture (January 16, 2024)
  • K221767 — Surgical Sutures with or without Needle (July 31, 2023)
  • K180701 — SafePath Suturing System (June 25, 2018)
  • K172149 — FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbabl (October 20, 2017)
  • K162396 — SILK Surgical Suture (November 23, 2016)
  • K160623 — FILASILK - Natural Non-absorbable Silk Surgical Suture, FILAMIDE - Non Absorbabl (May 31, 2016)
  • K080684 — WG-SURGICAL SUTURES WITH NEEDLE (June 9, 2008)
  • K071111 — NON-ABSORBABLE SILK SUTURE (July 17, 2007)

FDA data resources