Cleared Traditional

Intrauterine Access Balloon Catheter, Selective Salpingography Catheter

K181770 · Cook Incorporated · Obstetrics & Gynecology
Mar 2019
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K181770 is an FDA 510(k) clearance for the Intrauterine Access Balloon Catheter, Selective Salpingography Catheter, a Cannula, Manipulator/injector, Uterine (Class II — Special Controls, product code LKF), submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on March 29, 2019, 269 days after receiving the submission on July 3, 2018. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.4530.

Submission Details

510(k) Number K181770 FDA.gov
FDA Decision Cleared SESE
Date Received July 03, 2018
Decision Date March 29, 2019
Days to Decision 269 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code LKF — Cannula, Manipulator/injector, Uterine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.4530

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