Cleared Traditional

BUSSE UMBILICAL CORD CLAMP CUTTER

K021055 · Busse Hospital Disposables, Inc. · Obstetrics & Gynecology
Apr 2002
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K021055 is an FDA 510(k) clearance for the BUSSE UMBILICAL CORD CLAMP CUTTER, a Clamp, Umbilical (Class II — Special Controls, product code HFW), submitted by Busse Hospital Disposables, Inc. (Huntington, US). The FDA issued a Cleared decision on April 29, 2002, 28 days after receiving the submission on April 1, 2002. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number K021055 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 2002
Decision Date April 29, 2002
Days to Decision 28 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HFW — Clamp, Umbilical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.4530

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