Cleared Traditional

ECHOMARK INTRAUTERINE GUIDING CATHETER

K932436 · Echocath, Inc. · Obstetrics & Gynecology

Nov 1995

Decision

911d

Days

Class 2

Risk

About This 510(k) Submission

K932436 is an FDA 510(k) clearance for the ECHOMARK INTRAUTERINE GUIDING CATHETER, a Catheters, Salpingography (Class II — Special Controls, product code MOV), submitted by Echocath, Inc. (Princeton, US). The FDA issued a Cleared decision on November 16, 1995, 911 days after receiving the submission on May 19, 1993. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number	K932436 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 19, 1993
Decision Date	November 16, 1995
Days to Decision	911 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF