Cleared Traditional

CONCEPTUS FALLOPIAN TUBE CATHETERIZATION SYSTEM

K953314 · Conceptus, Inc. · Obstetrics & Gynecology

Jul 1995

Decision

16d

Days

Class 2

Risk

About This 510(k) Submission

K953314 is an FDA 510(k) clearance for the CONCEPTUS FALLOPIAN TUBE CATHETERIZATION SYSTEM, a Catheters, Salpingography (Class II — Special Controls, product code MOV), submitted by Conceptus, Inc. (San Carlos, US). The FDA issued a Cleared decision on July 28, 1995, 16 days after receiving the submission on July 12, 1995. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number	K953314 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 12, 1995
Decision Date	July 28, 1995
Days to Decision	16 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Statement