Cleared Traditional

C-E BRUSH

K881921 · Surgipath Medical Industries, Inc. · Obstetrics & Gynecology
Jul 1988
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K881921 is an FDA 510(k) clearance for the C-E BRUSH, a Spatula, Cervical, Cytological (Class II — Special Controls, product code HHT), submitted by Surgipath Medical Industries, Inc. (Grayslake, US). The FDA issued a Cleared decision on July 19, 1988, 71 days after receiving the submission on May 9, 1988. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number K881921 FDA.gov
FDA Decision Cleared SESE
Date Received May 09, 1988
Decision Date July 19, 1988
Days to Decision 71 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary —

Device Classification

Product Code HHT — Spatula, Cervical, Cytological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.4530

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