Cleared Traditional

EURO-MED ENDO-CURETTE

K882606 · Buckman Co., Inc. · Obstetrics & Gynecology

Jul 1988

Decision

31d

Days

Class 2

Risk

About This 510(k) Submission

K882606 is an FDA 510(k) clearance for the EURO-MED ENDO-CURETTE, a Sampler, Endocervical (Class II — Special Controls, product code PCF), submitted by Buckman Co., Inc. (Martinez, US). The FDA issued a Cleared decision on July 25, 1988, 31 days after receiving the submission on June 24, 1988. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1050.

Submission Details

510(k) Number	K882606 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 24, 1988
Decision Date	July 25, 1988
Days to Decision	31 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.