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510(k) K943216

SURGIDEK by Sutures , Ltd. — Product Code GAR

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)
  • K943627 — SURGISILK (December 5, 1994)
  • K943223 — SURGIDEK B (December 5, 1994)
  • K943218 — CHROMIC CATGUT (December 5, 1994)
  • K943221 — SURGIBOND (December 5, 1994)
  • K943220 — SUTULENE (December 5, 1994)
  • K943222 — SURGIDEK S (December 5, 1994)
  • K865038 — SURGISTEEL (June 30, 1987)

Other clearances for product code GAR

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  • 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)