ViaMed 15010
ViaMed 15010 is a Class II device made by Rece International Corp., cleared under FDA 510(k) K950780 on 25 Jul 1995 and listed in FDA GUDID since 23 May 2017 (UDI-DI 00811382011085), active as of 22 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 | Number00811382011085 | Date23 May 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK950780 | Date25 Jul 1995 | StatusActive |
Official records
- AccessGUDID record 00811382011085
- FDA 510(k) database K950780
Across registries
- FDA 510(k) K950780 decided 25 Jul 1995 Active
- FDA GUDID UDI-DI 00811382011085 listed 23 May 2017 Listed
Timeline
- Cleared FDA 510(k) K950780
- Listed FDA GUDID 00811382011085
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ViaMed
- Generic name
- Cervical cytology scraper, single-use
- Model / reference
- 15010
- Primary DI / UDI-DI
- 00811382011085
- 510(k) Number
- FDA product code
- HHT
- GMDN term
- Cervical cytology scraper, single-use
- Device class
- Class II
- Regulation number
- 884.4530
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code HHT (Spatula, Cervical, Cytological).
- BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY by Bio Nuclear Diagnostics Inc
- KOTEX SUPER MAXI PADS by KIMBERLY-CLARK CORPORATION
- SOFTPAP CERVICAL CELL COLLECTOR by Cytocore, Inc.
- PAP BRUSH by Young OU Brush Co.
- DIGENE CERVICAL BRUSH by Digene Corp.
- HARWILL MEDICAL CERVITULA CERVICAL SPATULA by Harwill Medical (Pty), Ltd.
- SURGI-PAP KIT by Surgipath Medical Industries, Inc.
- ORTHO* SPECIMEN COLLECTION CYTOBRUSH by Ortho Diagnostic Systems, Inc.
- DETECT CYTOLOGY BRUSH II by Cook Urological, Inc.
- CERVICAL SCRAPERS by Surgipath Medical Industries, Inc.