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) → HFC — Aspirator, Endocervical

# HFC · Aspirator, 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/HFC

## Overview

- **Product Code:** HFC
- **Device Name:** Aspirator, 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 (11 of 11)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K974032](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HFC/K974032.md) | ROCKET MUCUS SAMPLER SYRINGE, STERILE, ROCKET MUCUS SAMPLER SYRINGE, CLINICALLY ASPIRATOR | A & A Medical, Inc. | Dec 22, 1997 | SESE |
| [K960263](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HFC/K960263.md) | CERVICAL MUCOUS ASPIRATION CATHETER | Cook Urological, Inc. | Aug 29, 1996 | SESE |
| [K954903](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HFC/K954903.md) | PEDI VAGINAL ASPIRATOR | Cook Urological, Inc. | Apr 29, 1996 | SESE |
| [K954102](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HFC/K954102.md) | SELECTMUCUS | Select Medical Systems, Inc. | Nov 21, 1995 | SESE |
| [K902242](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HFC/K902242.md) | ENDOCERVICAL ASPIRATOR | Innovative Medical Products, Inc. | Oct 9, 1990 | SESE |
| [K902032](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HFC/K902032.md) | O. B. PACK IV | Customed, Inc. | Sep 28, 1990 | SESE |
| [K902954](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HFC/K902954.md) | OBER2 MONITOR, EYE MOVEMENT (OPHTHALMIC) | Permobil AB | Aug 23, 1990 | SESE |
| [K895403](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HFC/K895403.md) | ASPIRETTE ENDOCERVICAL ASPIRATOR | Unimar, Inc. | Nov 29, 1989 | SESE |
| [K821134](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HFC/K821134.md) | DC PACK TM | Seamless Hospital Products Co. | Jun 22, 1982 | SESE |
| [K812175](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HFC/K812175.md) | ENDOCERVICAL ASPIRATOR | Fertility Instrumentation, Inc. | Sep 21, 1981 | SESE |
| [K801238](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HFC/K801238.md) | ACCU-PAP T ZONE SAMPLER | Robert Hasselbrack, M.D. | Aug 12, 1980 | SESE |

## Top Applicants

- Cook Urological, Inc. — 2 clearances
- A & A Medical, Inc. — 1 clearance
- Customed, Inc. — 1 clearance
- Fertility Instrumentation, Inc. — 1 clearance
- Innovative Medical Products, Inc. — 1 clearance

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

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