Cleared Traditional

OVAMED INTRAUTERINE ACCESS CATHETER

K931534 · Ovamed Corp. · Obstetrics & Gynecology
Jul 1995
Decision
851d
Days
Class 2
Risk

About This 510(k) Submission

K931534 is an FDA 510(k) clearance for the OVAMED INTRAUTERINE ACCESS CATHETER, a Catheters, Salpingography (Class II — Special Controls, product code MOV), submitted by Ovamed Corp. (Sunnyvale, US). The FDA issued a Cleared decision on July 28, 1995, 851 days after receiving the submission on March 29, 1993. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number K931534 FDA.gov
FDA Decision Cleared SESE
Date Received March 29, 1993
Decision Date July 28, 1995
Days to Decision 851 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