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510(k) K212603

Non Absorbable Surgical Nylon Suture by Shandong Haidike Medical Product Co., Ltd. — Product Code GAR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2021
Date Received
August 17, 2021
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 Shandong Haidike Medical Product Co., Ltd.

  • K232355 — Non absorbable Surgical Silk Suture (January 16, 2024)

Other clearances for product code GAR

  • K220980 — Tissue Approximation System (TAS) (July 5, 2023)
  • K212888 — Golnit Nylon Monofilament Suture (March 31, 2022)
  • 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)
  • K053637 — MANI NEEDLE & SUTURE PACK (NYLON) (May 19, 2006)