CROWNJUN Nylon Suture NCM00X
CROWNJUN Nylon Suture NCM00X 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 9 Oct 2025 (UDI-DI 04946585035807), 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 | Number04946585035807 | Date9 Oct 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK192420 | Date29 May 2020 | StatusActive |
Official records
- AccessGUDID record 04946585035807
- FDA 510(k) database K192420
Across registries
- FDA 510(k) K192420 decided 29 May 2020 Active
- FDA GUDID UDI-DI 04946585035807 listed 9 Oct 2025 Listed
Timeline
- Cleared FDA 510(k) K192420
- Listed FDA GUDID 04946585035807
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- Withdrawn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
- NCM00X
- Primary DI / UDI-DI
- 04946585035807
- 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
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