Syvek Patch 400-02
by Marine Polymer Technologies, Inc.
Syvek Patch 400-02 is a Class I device made by Marine Polymer Technologies, Inc., cleared under FDA 510(k) K984177 on 18 Dec 1998 and listed in FDA GUDID since 20 Jan 2020 (UDI-DI 00389142000087), 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 | Number00389142000087 | Date20 Jan 2020 | StatusListed |
| United States | FDA 510(k)SN | NumberK984177 | Date18 Dec 1998 | StatusActive |
Official records
- AccessGUDID record 00389142000087
- FDA 510(k) database K984177
Across registries
- FDA 510(k) K984177 decided 18 Dec 1998 Active
- FDA GUDID UDI-DI 00389142000087 listed 20 Jan 2020 Listed
Timeline
- Cleared FDA 510(k) K984177
- Listed FDA GUDID 00389142000087
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Syvek Patch
- Generic name
- Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial
- Model / reference
- 400-02
- Primary DI / UDI-DI
- 00389142000087
- 510(k) Number
- FDA product code
- KMF
- GMDN term
- Plant polysaccharide haemostatic agent, non-bioabsorbable, non-antimicrobial
- Device class
- Class I
- Regulation number
- 880.5090
- GUDID distribution status
- In Commercial Distribution
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