Disposable Needle Guide 5285
by Protek Medical Products, Inc.
Disposable Needle Guide 5285 is a needle guide (FDA Class II; FDA product code ITX, Transducer, Ultrasonic, Diagnostic) made by Protek Medical Products, Inc., cleared under FDA 510(k) K971722 on 10 Jul 1997 (1 earlier submission) and listed in FDA GUDID since 23 Mar 2018 (UDI-DI 10841912105455), 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 | Number10841912105455 | Date23 Mar 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK971722 | Date10 Jul 1997 | StatusActive |
Official records
- AccessGUDID record 10841912105455
- FDA 510(k) database K971722
- FDA 510(k) database K971115
Across registries
- FDA 510(k) K971722 decided 10 Jul 1997 Active
- FDA GUDID UDI-DI 10841912105455 listed 23 Mar 2018 Listed
Timeline
- Cleared FDA 510(k) K971115
- Cleared FDA 510(k) K971722
- Listed FDA GUDID 10841912105455
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Disposable Needle Guide
- Generic name
- Needle guide, single-use
- Model / reference
- 5285
- Primary DI / UDI-DI
- 10841912105455
- FDA product code
- ITX
- GMDN term
- Needle guide, single-use
- Device class
- Class II
- Regulation number
- 892.1570
- GUDID distribution status
- In Commercial Distribution
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