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510(k) K931914

SUTURE NON-ABSORBABLE SYNTHETIC POLYLMIDE by Surgimetrics International, Ltd. — Product Code GAR

K931914 is an FDA 510(k) premarket notification submitted by Surgimetrics International, Ltd. for the device "SUTURE NON-ABSORBABLE SYNTHETIC POLYLMIDE". The FDA issued a decision of Substantially Equivalent on October 5, 1994. The device falls under product code GAR (Suture, Nonabsorbable, Synthetic, Polyamide), a Class II device regulated under 21 CFR 878.5020. Surgimetrics International, Ltd. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 1994
Date Received
April 16, 1993
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 Surgimetrics International, Ltd.

  • K931919 — CATGUT SUTURE CHROMIC (March 3, 1994)
  • K931913 — SUTURE NON-ABSORBABLE SILK (March 3, 1994)
  • K931915 — STAINLESS STEEL SUTURE (March 3, 1994)
  • K931916 — SUTURE NON-ABSORBABLE SYNTHETIC POLYESTER (March 3, 1994)
  • K931918 — CATGUT SUTURE PLAIN (March 3, 1994)
  • K931917 — SUTURE NON-ABSORBABLE SYNTHETIC POLYPROPYLENE (March 3, 1994)

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