Cleared Traditional

NOVY CORNUAL CANNULATION SET

K931476 · Cook Ob/Gyn · Obstetrics & Gynecology
Jul 1995
Decision
856d
Days
Class 2
Risk

About This 510(k) Submission

K931476 is an FDA 510(k) clearance for the NOVY CORNUAL CANNULATION SET, a Catheters, Salpingography (Class II — Special Controls, product code MOV), submitted by Cook Ob/Gyn (Spencer, US). The FDA issued a Cleared decision on July 28, 1995, 856 days after receiving the submission on March 24, 1993. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number K931476 FDA.gov
FDA Decision Cleared SESE
Date Received March 24, 1993
Decision Date July 28, 1995
Days to Decision 856 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Statement

Device Classification

Product Code MOV — Catheters, Salpingography
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.4530