Disposable Needle Guide 5055
by Protek Medical Products, Inc.
Disposable Needle Guide 5055 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 25 Apr 2017 (UDI-DI 20841912104059), 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 | Number20841912104059 | Date25 Apr 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK971722 | Date10 Jul 1997 | StatusActive |
Official records
- AccessGUDID record 20841912104059
- 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 20841912104059 listed 25 Apr 2017 Listed
Timeline
- Cleared FDA 510(k) K971115
- Cleared FDA 510(k) K971722
- Listed FDA GUDID 20841912104059
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- Withdrawn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
- 5055
- Primary DI / UDI-DI
- 20841912104059
- 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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