Cleared Traditional

VASOVASOSTOMY SET

K921546 · Cook Urological, Inc. · Gastroenterology & Urology
Jul 1993
Decision
457d
Days
Class 1
Risk

About This 510(k) Submission

K921546 is an FDA 510(k) clearance for the VASOVASOSTOMY SET, a Surgical Instruments, G-u, Manual (and Accessories) (Class I — General Controls, product code KOA), submitted by Cook Urological, Inc. (Spencer, US). The FDA issued a Cleared decision on July 2, 1993, 457 days after receiving the submission on April 1, 1992. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.4730.

Submission Details

510(k) Number K921546 FDA.gov
FDA Decision Cleared SESK
Date Received April 01, 1992
Decision Date July 02, 1993
Days to Decision 457 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement

Device Classification

Product Code KOA — Surgical Instruments, G-u, Manual (and Accessories)
Device Class Class I — General Controls
CFR Regulation 21 CFR 876.4730