CROWNJUN Nylon Suture NDU00W
CROWNJUN Nylon Suture NDU00W 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 04946585042201), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number04946585042201 | Date13 Nov 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK192420 | Date29 May 2020 | StatusActive |
Official records
- AccessGUDID record 04946585042201
- FDA 510(k) database K192420
Across registries
- FDA 510(k) K192420 decided 29 May 2020 Active
- FDA GUDID UDI-DI 04946585042201 listed 13 Nov 2025 Listed
Timeline
- Cleared FDA 510(k) K192420
- Listed FDA GUDID 04946585042201
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- CROWNJUN Nylon Suture
- Generic name
- Nylon suture, non-bioabsorbable, monofilament
- Model / reference
- NDU00W
- Primary DI / UDI-DI
- 04946585042201
- 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
Similar devices
Other devices filed under FDA product code GAR (Suture, Nonabsorbable, Synthetic, Polyamide).
- DemeLON NM50630 by DemeTECH Corp
- DemeLON NL560135BI0P by DemeTECH Corp
- NUROLON C512D by Ethicon Inc.
- Onatec OL318045 by Surgical Specialties México, S. de R.L. de C.V.
- Onatec OL468041 by Surgical Specialties México, S. de R.L. de C.V.
- MANI NEEDLE & SUTURE PACK (NYLON) by MANI, INC.
- NON-ABSORBABLE SURGICAL SUTURES by Alcon Laboratories, Inc.
- NYLAMID SUTURE by S. Jackson, Inc.
- NONABSORBABLE NYLON SURGICAL SUTURE* by United States Surgical, A Division of Tyco Healthc
- SILK SUTURES-REVISED LABELING by Look, Inc.