Cleared Traditional

CONCEPTUS FALLOPIAN TUBE CATHETEIZATION WITH MICROENDOSCOPY SYSTEM

K962587 · Conceptus, Inc. · Obstetrics & Gynecology

Jan 1997

Decision

214d

Days

Class 2

Risk

About This 510(k) Submission

K962587 is an FDA 510(k) clearance for the CONCEPTUS FALLOPIAN TUBE CATHETEIZATION WITH MICROENDOSCOPY SYSTEM, a Falloposcope (Class II — Special Controls, product code MKO), submitted by Conceptus, Inc. (San Carlos, US). The FDA issued a Cleared decision on January 31, 1997, 214 days after receiving the submission on July 1, 1996. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.1690.

Submission Details

510(k) Number	K962587 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 01, 1996
Decision Date	January 31, 1997
Days to Decision	214 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF