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510(k) K032160

ARTELON SURGICAL SUTURE by Artimplant AB — Product Code GAR

K032160 is an FDA 510(k) premarket notification submitted by Artimplant AB for the device "ARTELON SURGICAL SUTURE". The FDA issued a decision of Substantially Equivalent on November 17, 2003. The device falls under product code GAR (Suture, Nonabsorbable, Synthetic, Polyamide), a Class II device regulated under 21 CFR 878.5020. Artimplant AB has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2003
Date Received
July 15, 2003
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 Artimplant AB

  • K071887 — SPORTMESH OR ARTELON TISSUE REINFORCEMENT (September 18, 2007)
  • K061956 — ARTELON STT SPACER (June 7, 2007)
  • K061954 — ARTELON CMC SPACER ARTHRO (June 1, 2007)
  • K052830 — SPORTMESH (January 19, 2006)
  • K052482 — ARTELON SURGICAL SUTURE (October 17, 2005)
  • K040070 — ARTELON SPACER CMC-1 (September 21, 2004)

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