Cleared Traditional

CATHETERS, MALE, FEMALE

K892691 · Zinnanti Surgical Instruments, Inc. · Gastroenterology & Urology
Jun 1989
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K892691 is an FDA 510(k) clearance for the CATHETERS, MALE, FEMALE, a Catheter, Urological (Class II — Special Controls, product code KOD), submitted by Zinnanti Surgical Instruments, Inc. (Chatsworth, US). The FDA issued a Cleared decision on June 23, 1989, 71 days after receiving the submission on April 13, 1989. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5130.

Submission Details

510(k) Number K892691 FDA.gov
FDA Decision Cleared SESE
Date Received April 13, 1989
Decision Date June 23, 1989
Days to Decision 71 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary —

Device Classification

Product Code KOD — Catheter, Urological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5130

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