Cleared Traditional

BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U

K022434 · C.R. Bard, Inc. · Gastroenterology & Urology
Aug 2002
Decision
11d
Days
Class 2
Risk

About This 510(k) Submission

K022434 is an FDA 510(k) clearance for the BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U, a Ligator, Esophageal (Class II — Special Controls, product code MND), submitted by C.R. Bard, Inc. (Billerica, US). The FDA issued a Cleared decision on August 5, 2002, 11 days after receiving the submission on July 25, 2002. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4400.

Submission Details

510(k) Number K022434 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 2002
Decision Date August 05, 2002
Days to Decision 11 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code MND — Ligator, Esophageal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.4400

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