Cleared Special

SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla

K213547 · Ttk Healthcare Limited · Obstetrics & Gynecology
Dec 2021
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K213547 is an FDA 510(k) clearance for the SKORE Smooth Condoms - SKORE Colors & Flavors, SKORE Smooth Condoms - SKORE Vanilla, a Condom (Class II — Special Controls, product code HIS), submitted by Ttk Healthcare Limited (Puducherry, IN). The FDA issued a Cleared decision on December 23, 2021, 45 days after receiving the submission on November 8, 2021. This device falls under the Obstetrics & Gynecology review panel. Regulated under 21 CFR 884.5300.

Submission Details

510(k) Number K213547 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 2021
Decision Date December 23, 2021
Days to Decision 45 days
Submission Type Special
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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