Cleared Traditional

METEL URETERAL BASKET STONE DISLODGER

K951761 · Annex Medical, Inc. · Gastroenterology & Urology
May 1995
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K951761 is an FDA 510(k) clearance for the METEL URETERAL BASKET STONE DISLODGER, a Dislodger, Stone, Basket, Ureteral, Metal (Class II — Special Controls, product code FFL), submitted by Annex Medical, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on May 11, 1995, 24 days after receiving the submission on April 17, 1995. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4680.

Submission Details

510(k) Number K951761 FDA.gov
FDA Decision Cleared SESE
Date Received April 17, 1995
Decision Date May 11, 1995
Days to Decision 24 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code FFL — Dislodger, Stone, Basket, Ureteral, Metal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.4680

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