Cleared Traditional

K230049 - SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine (FDA 510(k) Clearance)

Also includes:

SKORE Bulbous Condoms - SKORE WARM, SKORE COOL SKORE Benzocaine Condoms - SKORE NOTHING Climax Delay, SKORE DUO MAX, SKORE NOT OUT

K230049 · Ttk Healthcare Limited · Obstetrics & Gynecology device

Sep 2023

Decision

244d

Days

Class 2

Risk

K230049 is an FDA 510(k) clearance for the SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots, SKORE NOTHING Strawberry, SKORE NOTHING Chocolate, SKORE SKIN THIN Ultra fine. This device is classified as a Condom (Class II - Special Controls, product code HIS).

Submitted by Ttk Healthcare Limited (Puducherry, IN). The FDA issued a Cleared decision on September 7, 2023, 244 days after receiving the submission on January 6, 2023.

This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.5300.

Submission Details

510(k) Number	K230049 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 06, 2023
Decision Date	September 07, 2023
Days to Decision	244 days
Submission Type	Traditional
Review Panel	Obstetrics & Gynecology (OB)
Summary	Summary PDF