Cleared Traditional

URETHRAL AND URETERAL BALLOON DILATATORS

K884711 · Primrose Medical, Inc. · Gastroenterology & Urology
Sep 1989
Decision
325d
Days
Class 2
Risk

About This 510(k) Submission

K884711 is an FDA 510(k) clearance for the URETHRAL AND URETERAL BALLOON DILATATORS, a Dilator, Catheter, Ureteral (Class II — Special Controls, product code EZN), submitted by Primrose Medical, Inc. (Woburn, US). The FDA issued a Cleared decision on September 29, 1989, 325 days after receiving the submission on November 8, 1988. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5470.

Submission Details

510(k) Number K884711 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 1988
Decision Date September 29, 1989
Days to Decision 325 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code EZN — Dilator, Catheter, Ureteral
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5470

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