FDA product code PCF: Sampler, Endocervical
PCF is the FDA product code for sampler, endocervical. It is a Class II device, regulated under 21 CFR 884.1050 and reviewed by the Obstetrics and Gynecology panel. FDA has cleared 5 510(k) submissions under PCF, from 5 different applicants. The average 510(k) review took 75 days (median 35).
Definition
Obtains tissue samples from the endocervical canal for histological analysis.
Classification
| Field | Value |
|---|---|
| Device name | Sampler, Endocervical |
| Device class | Class II |
| Regulation | 21 CFR 884.1050 |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Obstetrics/Gynecology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every PCF clearance
Top PCF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Femasys, Inc. | 1 | 2012-12-20 |
| Femspec LLC | 1 | 2006-07-28 |
| Buckman Co., Inc. | 1 | 1988-07-25 |
| Euro-Med Intl. | 1 | 1988-07-08 |
| Roland J. Zwick, Inc. | 1 | 1986-04-08 |
Most recent PCF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K122658 | Femasys, Inc. | FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009 | 2012-12-20 | 111 |
| K060320 | Femspec LLC | FEMECC ENDOCERVICAL CURETTE | 2006-07-28 | 170 |
| K882606 | Buckman Co., Inc. | EURO-MED ENDO-CURETTE | 1988-07-25 | 31 |
| K882404 | Euro-Med Intl. | KEVOR-CURETTE | 1988-07-08 | 28 |
| K860796 | Roland J. Zwick, Inc. | DISPO-URETTE | 1986-04-08 | 35 |
Recalls for PCF devices
openFDA lists no recalls for product code PCF.
Frequently asked questions
What is FDA product code PCF?
PCF is the FDA product code for sampler, endocervical. It is a Class II device, regulated under 21 CFR 884.1050 and reviewed by the Obstetrics and Gynecology panel.
What device class is PCF?
Class II, regulation 21 CFR 884.1050. Typical premarket route: 510(k).
How long does a 510(k) take for product code PCF?
Across 5 cleared submissions the average was 75 days from receipt to decision (median 35).
Which companies have the most PCF clearances?
Femasys, Inc. (1); Femspec LLC (1); Buckman Co., Inc. (1); Euro-Med Intl. (1); Roland J. Zwick, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PCF
- Run a recall and safety report across every PCF manufacturer
- Watch product code PCF for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Obstetrics and Gynecology product codes · FDA product code lookup · 510(k) database search · 510(k) review times