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510(k) K212888

Golnit Nylon Monofilament Suture by Antarma, LLC Dba Golnit Sutures — Product Code GAR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 2022
Date Received
September 10, 2021
Clearance Type
Abbreviated
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 Antarma, LLC Dba Golnit Sutures

  • K192088 — GOLNIT Non-aborbable PTFE Surgical Suture (September 4, 2019)

Other clearances for product code GAR

  • K220980 — Tissue Approximation System (TAS) (July 5, 2023)
  • 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)
  • K060471 — FSSB NYLON SURGICAL SUTURES (July 26, 2006)
  • K053637 — MANI NEEDLE & SUTURE PACK (NYLON) (May 19, 2006)