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510(k) K192420

Crownjun Nylon Suture by Kono Seisakusho Co., Ltd. — Product Code GAR

K192420 is an FDA 510(k) premarket notification submitted by Kono Seisakusho Co., Ltd. for the device "Crownjun Nylon Suture". The FDA issued a decision of Substantially Equivalent on May 29, 2020. The device falls under product code GAR (Suture, Nonabsorbable, Synthetic, Polyamide), a Class II device regulated under 21 CFR 878.5020. Kono Seisakusho Co., Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2020
Date Received
September 4, 2019
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 Kono Seisakusho Co., Ltd.

  • K230281 — PICOCLAMP (October 23, 2023)

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)
  • 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)

FDA data resources