Disposable Needle Guide 5560
by Protek Medical Products, Inc.
Part of a family of 41 devices: see the family page
Ref 1-710-5560
Disposable Needle Guide 5560 is a needle guide (EU MDR Class I; FDA Class II; FDA product code ITX, Transducer, Ultrasonic, Diagnostic) made by Protek Medical Products, Inc., registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI 084191215000NSMV), cleared under FDA 510(k) K971722 on 10 Jul 1997 (1 earlier submission) and listed in FDA GUDID since 8 Feb 2019 (UDI-DI 10841912105943), active as of 7 Nov 2026.
Active
Valid until
No date given
FDA recalls
None found
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number084191215000NSMV 10841912105943 | Date27 Oct 2026 | StatusActive |
| United States | GUDID listing GUDID | Number10841912105943 | Date8 Feb 2019 | StatusListed |
| United States | FDA 510(k)SESE GUDID | NumberK971722 | Date10 Jul 1997 | StatusActive |
Official records
- EUDAMED public site 084191215000NSMV
- AccessGUDID record 10841912105943
- FDA 510(k) database K971722
- FDA 510(k) database K971115
Across registries
- EUDAMED Basic UDI-DI 084191215000NSMV registered 27 Oct 2026 Active
- FDA 510(k) K971722 decided 10 Jul 1997 Active
- FDA GUDID UDI-DI 10841912105943 listed 8 Feb 2019 Listed
Certificates
No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.
Timeline
- Cleared FDA 510(k) K971115
- Cleared FDA 510(k) K971722
- Listed FDA GUDID 10841912105943
- Registered EUDAMED 084191215000NSMV
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- Trade name
- aspen surgical® EUDAMEDDisposable Needle Guide GUDID
- Generic name
- Needle guide, single-use
- Device name
- Needle Guides (non sterile)
- Model / Ref / Catalog
- 1-710-5560 EUDAMED5560 GUDID
- Primary DI / UDI-DI
- 10841912105943
- Basic UDI-DI
- 084191215000NSMV
- FDA product code
- ITX
- EMDN code
- A018002 Needle guides
- GMDN term
- Needle guide, single-use
- Device class
- Class I EUDAMEDClass II GUDID
- Regulation number
- 892.1570
- EU registration type
- Standard device
- EU market of registration
- Netherlands
- GUDID distribution status
- In Commercial Distribution
Truth per registry
| Field | EUDAMED | GUDID |
|---|---|---|
| Model / reference | 1-710-5560 | 5560 |
| Device class | Class I | Class II |
| Sterilise before use | Yes | No |
Registry differences
EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:
- Sterilise before use UDI-DI 10841912105943: EUDAMED states Yes, FDA GUDID states No.
Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.
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