Cleared Special

BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U

K033245 · C.R. Bard, Inc. · Gastroenterology & Urology
Nov 2003
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K033245 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 November 6, 2003, 30 days after receiving the submission on October 7, 2003. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4400.

Submission Details

510(k) Number K033245 FDA.gov
FDA Decision Cleared SESE
Date Received October 07, 2003
Decision Date November 06, 2003
Days to Decision 30 days
Submission Type Special
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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