Cleared Traditional

METAL URETERAL BASKET STONE DISLODGER

K896169 · Annex Medical, Inc. · Gastroenterology & Urology
Dec 1989
Decision
54d
Days
Class 2
Risk

About This 510(k) Submission

K896169 is an FDA 510(k) clearance for the METAL 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 December 18, 1989, 54 days after receiving the submission on October 25, 1989. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4680.

Submission Details

510(k) Number K896169 FDA.gov
FDA Decision Cleared SESE
Date Received October 25, 1989
Decision Date December 18, 1989
Days to Decision 54 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

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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