PCF — Sampler, Endocervical Class II
FDA product code PCF covers "Sampler, Endocervical", a Class II medical device regulated under 21 CFR 884.1050. Submissions are reviewed by the Obstetrics/Gynecology panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- PCF
- Device Class
- Class II
- Regulation Number
- 884.1050
- Submission Type
- 510(k)
- Review Panel
- OB
- Medical Specialty
- Obstetrics/Gynecology
- Implant
- No
Definition
Obtains tissue samples from the endocervical canal for histological analysis.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K122658 | Femasys | FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF… | Dec 20, 2012 |
| K060320 | Femspec | FEMECC ENDOCERVICAL CURETTE | Jul 28, 2006 |
| K882606 | Buckman Co | EURO-MED ENDO-CURETTE | Jul 25, 1988 |
| K882404 | Euro-Med Intl | KEVOR-CURETTE | Jul 8, 1988 |
| K860796 | Roland J. Zwick | DISPO-URETTE | Apr 8, 1986 |