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CROWNJUN Nylon Suture NDM01X

by Kono Seisakusho Co., Ltd.

CROWNJUN Nylon Suture NDM01X is a Class II device made by Kono Seisakusho Co., Ltd., cleared under FDA 510(k) K192420 on 29 May 2020 and listed in FDA GUDID since 13 Nov 2025 (UDI-DI 04946585041938), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K192420

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04946585041938 UDI-DI Date13 Nov 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK192420 Date29 May 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K192420 decided 29 May 2020 Active
  • FDA GUDID UDI-DI 04946585041938 listed 13 Nov 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K192420
  2. Listed FDA GUDID 04946585041938

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
CROWNJUN Nylon Suture
Generic name
Nylon suture, non-bioabsorbable, monofilament
Model / reference
NDM01X
Primary DI / UDI-DI
04946585041938
510(k) Number
FDA product code
GAR
GMDN term
Nylon suture, non-bioabsorbable, monofilament
Device class
Class II
Regulation number
878.5020
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K192420)

and 8 more cleared under K192420

Similar devices

Other devices filed under FDA product code GAR (Suture, Nonabsorbable, Synthetic, Polyamide).

Other devices from Kono Seisakusho Co., Ltd.

See all devices from Kono Seisakusho Co., Ltd. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)