PCF · Sampler, Endocervical
Obstetrics/Gynecology · 21 CFR 884.1050 · Class 2
Overview
| Product Code | PCF |
|---|---|
| Device Name | Sampler, Endocervical |
| Regulation | 21 CFR 884.1050 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
Identification
An endocervical aspirator is a device designed to remove tissue from the endocervix (mucous membrane lining the canal of the cervix of the uterus) by suction with a syringe, bulb and pipette, or catheter. This device is used to evaluate endocervical tissue to detect malignant and premalignant lesions.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K122658 | FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009 | Femasys, Inc. | Dec 20, 2012 | SESE |
| K060320 | FEMECC ENDOCERVICAL CURETTE | Femspec LLC | Jul 28, 2006 | SESE |
| K882606 | EURO-MED ENDO-CURETTE | Buckman Co., Inc. | Jul 25, 1988 | SESE |
| K882404 | KEVOR-CURETTE | Euro-Med Intl. | Jul 8, 1988 | SESE |
| K860796 | DISPO-URETTE | Roland J. Zwick, Inc. | Apr 8, 1986 | SESE |
Top Applicants
- Roland J. Zwick, Inc. — 1 clearance
- Femspec LLC — 1 clearance
- Femasys, Inc. — 1 clearance
- Euro-Med Intl. — 1 clearance
- Buckman Co., Inc. — 1 clearance
