Cleared Traditional

K897070 - ENDOBRUSH(TM) DEVICE; OMNIBRUSH
(FDA 510(k) Clearance)

K897070 · Intl. Cytobrush, Inc. · Obstetrics & Gynecology

Sep 1990

Decision

262d

Days

Class 2

Risk

K897070 is an FDA 510(k) clearance for the ENDOBRUSH(TM) DEVICE; OMNIBRUSH. This device is classified as a Brush, Endometrial (Class II — Special Controls, product code HFE).

Submitted by Intl. Cytobrush, Inc. (Hollywood, US). The FDA issued a Cleared decision on September 10, 1990, 262 days after receiving the submission on December 22, 1989.

This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.1100.

Submission Details

510(k) Number	K897070 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 22, 1989
Decision Date	September 10, 1990
Days to Decision	262 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	—