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510(k) K020146

SERRALNYL by Serral, S.A. DE C.V. — Product Code GAR

K020146 is an FDA 510(k) premarket notification submitted by Serral, S.A. DE C.V. for the device "SERRALNYL". The FDA issued a decision of Substantially Equivalent on April 15, 2002. The device falls under product code GAR (Suture, Nonabsorbable, Synthetic, Polyamide), a Class II device regulated under 21 CFR 878.5020. Serral, S.A. DE C.V. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 2002
Date Received
January 16, 2002
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 Serral, S.A. DE C.V.

  • K033762 — SERRALAPG (March 15, 2004)
  • K020597 — SERRALGUT (August 14, 2002)
  • K020902 — SERRALESTER (May 20, 2002)
  • K020901 — SERRALSILK (April 26, 2002)
  • K020265 — SERRALENE, MODEL CATALOG NO 1S (March 8, 2002)

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