← Product Code [HFC](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HFC) · K895403

# ASPIRETTE ENDOCERVICAL ASPIRATOR (K895403)

_Unimar, Inc. · HFC · Nov 29, 1989 · Obstetrics/Gynecology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HFC/K895403

## Device Facts

- **Applicant:** Unimar, Inc.
- **Product Code:** [HFC](/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HFC.md)
- **Decision Date:** Nov 29, 1989
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 884.1050
- **Device Class:** Class 2
- **Review Panel:** Obstetrics/Gynecology

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HFC/K895403](https://fda.innolitics.com/submissions/OB/subpart-b%E2%80%94obstetrical-and-gynecological-diagnostic-devices/HFC/K895403)

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