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510(k) K943216

SURGIDEK by Sutures , Ltd. — Product Code GAR

K943216 is an FDA 510(k) premarket notification submitted by Sutures , Ltd. for the device "SURGIDEK". The FDA issued a decision of SN on December 5, 1994. The device falls under product code GAR (Suture, Nonabsorbable, Synthetic, Polyamide), a Class II device regulated under 21 CFR 878.5020. Sutures , Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SN ()
Decision Date
December 5, 1994
Date Received
July 5, 1994
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 Sutures , Ltd.

  • K990432 — SURGISORB (May 27, 1999)
  • K953609 — PRODEK (January 31, 1996)
  • K943217 — PLAIN CATGUT (December 5, 1994)
  • K943220 — SUTULENE (December 5, 1994)
  • K943222 — SURGIDEK S (December 5, 1994)
  • K943627 — SURGISILK (December 5, 1994)
  • K943221 — SURGIBOND (December 5, 1994)
  • K943223 — SURGIDEK B (December 5, 1994)
  • K943218 — CHROMIC CATGUT (December 5, 1994)
  • K865038 — SURGISTEEL (June 30, 1987)

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