Cleared Traditional

KEVOR-CURETTE

K882404 · Euro-Med Intl. · Obstetrics & Gynecology
Jul 1988
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K882404 is an FDA 510(k) clearance for the KEVOR-CURETTE, a Sampler, Endocervical (Class II — Special Controls, product code PCF), submitted by Euro-Med Intl. (Alameda, US). The FDA issued a Cleared decision on July 8, 1988, 28 days after receiving the submission on June 10, 1988. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1050.

Submission Details

510(k) Number K882404 FDA.gov
FDA Decision Cleared SESE
Date Received June 10, 1988
Decision Date July 08, 1988
Days to Decision 28 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary —

Device Classification

Product Code PCF — Sampler, Endocervical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.1050
Definition Obtains Tissue Samples From The Endocervical Canal For Histological Analysis.