Browse hierarchy: [Obstetrics/Gynecology (OB)](/submissions/OB) → [Subpart B — Obstetrical and Gynecological Diagnostic Devices](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices) → [21 CFR 884.1050](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/884.1050) → PCF — Sampler, Endocervical

# PCF · Sampler, Endocervical

_Obstetrics/Gynecology · 21 CFR 884.1050 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/PCF

## Overview

- **Product Code:** PCF
- **Device Name:** Sampler, Endocervical
- **Regulation:** [21 CFR 884.1050](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/884.1050)
- **Device Class:** 2
- **Review Panel:** [Obstetrics/Gynecology](/submissions/OB)
- **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](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/PCF/K122658.md) | FEMCERV ENDOCERVICAL SAMPLER MODEL 3 SIZES: REF FCV-013, REF FCV-011, REF FCV-009 | Femasys, Inc. | Dec 20, 2012 | SESE |
| [K060320](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/PCF/K060320.md) | FEMECC ENDOCERVICAL CURETTE | Femspec LLC | Jul 28, 2006 | SESE |
| [K882606](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/PCF/K882606.md) | EURO-MED ENDO-CURETTE | Buckman Co., Inc. | Jul 25, 1988 | SESE |
| [K882404](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/PCF/K882404.md) | KEVOR-CURETTE | Euro-Med Intl. | Jul 8, 1988 | SESE |
| [K860796](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/PCF/K860796.md) | DISPO-URETTE | Roland J. Zwick, Inc. | Apr 8, 1986 | SESE |

## Top Applicants

- Buckman Co., Inc. — 1 clearance
- Euro-Med Intl. — 1 clearance
- Femasys, Inc. — 1 clearance
- Femspec LLC — 1 clearance
- Roland J. Zwick, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/PCF](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/PCF)

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