Cleared Traditional

MILL-ROSE DISPOSABLE POLYPECTOMY SNARE

K971275 · Mill-Rose Laboratory · Gastroenterology & Urology
May 1997
Decision
46d
Days
Class 2
Risk

About This 510(k) Submission

K971275 is an FDA 510(k) clearance for the MILL-ROSE DISPOSABLE POLYPECTOMY SNARE, a Snare, Flexible (Class II — Special Controls, product code FDI), submitted by Mill-Rose Laboratory (Mentor, US). The FDA issued a Cleared decision on May 23, 1997, 46 days after receiving the submission on April 7, 1997. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4300.

Submission Details

510(k) Number K971275 FDA.gov
FDA Decision Cleared SESE
Date Received April 07, 1997
Decision Date May 23, 1997
Days to Decision 46 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code FDI — Snare, Flexible
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.4300

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