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510(k) K003000

GRAMS NYLON NONABSORBABLE SUTURE by Gramsmed, LLC — Product Code GAR

K003000 is an FDA 510(k) premarket notification submitted by Gramsmed, LLC for the device "GRAMS NYLON NONABSORBABLE SUTURE". The FDA issued a decision of Substantially Equivalent on December 18, 2000. The device falls under product code GAR (Suture, Nonabsorbable, Synthetic, Polyamide), a Class II device regulated under 21 CFR 878.5020. Gramsmed, LLC has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 2000
Date Received
September 26, 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 Gramsmed, LLC

  • K021043 — GRAMS ABSORBABLE SURGICAL GUT SUTURE PLAIN & CHROMIC (June 21, 2002)
  • K010672 — MONOGRAMS SYNTHETIC MONOFILAMENT ABSORBABLE SUTURE (May 18, 2001)
  • K003017 — GRAMSORB SYNTHETIC ABSORBABLE SUTURE (March 13, 2001)
  • K003590 — GRAMS POLYESTER NONABSORBABLE SUTURE (March 5, 2001)
  • K002999 — GRAMS POLYPROPYLENE NONABSORBABLE SUTURE (December 18, 2000)
  • K003001 — GRAMS SILK NONABSORBABLE SUTURE (December 15, 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