Cleared Abbreviated

OKAMOTO STUDDED CONDOM

K141256 · Okamoto USA, Inc. · Obstetrics & Gynecology
Jul 2014
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K141256 is an FDA 510(k) clearance for the OKAMOTO STUDDED CONDOM, a Condom (Class II — Special Controls, product code HIS), submitted by Okamoto USA, Inc. (Washington, US). The FDA issued a Cleared decision on July 23, 2014, 70 days after receiving the submission on May 14, 2014. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5300.

Submission Details

510(k) Number K141256 FDA.gov
FDA Decision Cleared SESE
Date Received May 14, 2014
Decision Date July 23, 2014
Days to Decision 70 days
Submission Type Abbreviated
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF

Device Classification

Product Code HIS — Condom
Device Class Class II — Special Controls
CFR Regulation 21 CFR 884.5300

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