Pap Perfect 11080
Pap Perfect 11080 is a Class II device made by CooperSurgical, Inc., cleared under FDA 510(k) K861389 on 2 May 1986 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 20888937003165), 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 | Number20888937003165 | Date21 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK861389 | Date2 May 1986 | StatusActive |
Official records
- AccessGUDID record 20888937003165
- FDA 510(k) database K861389
Across registries
- FDA 510(k) K861389 decided 2 May 1986 Active
- FDA GUDID UDI-DI 20888937003165 listed 21 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K861389
- Listed FDA GUDID 20888937003165
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Pap Perfect
- Generic name
- Urogenital specimen collection kit IVD, clinical
- Model / reference
- 11080
- Primary DI / UDI-DI
- 20888937003165
- 510(k) Number
- FDA product code
- HHT
- GMDN term
- Urogenital specimen collection kit IVD, clinical
- Device class
- Class II
- Regulation number
- 884.4530
- GUDID distribution status
- In Commercial Distribution
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- CYCLO-BRUSH by MEDLINE INDUSTRIES, INC.
- ROVERS SPATULA by Rovers Medical Devices B.V.
- Kolplast Cervical Sample Collection Kit by Kolplast CI SA
- HISTOBRUSH by PURITAN MEDICAL PRODUCTS COMPANY LLC