Medical Device Manufacturer · US , Stratford , CT

Okamoto USA, Inc. - FDA 510(k) Cleared Devices

14 submissions · 14 cleared · Since 1987
14
Total
14
Cleared
0
Denied

Okamoto USA, Inc. has 14 FDA 510(k) cleared obstetrics & gynecology devices. Based in Stratford, US.

Latest FDA clearance: Feb 2025. Active since 1987.

Browse the complete list of FDA 510(k) cleared obstetrics & gynecology devices from this manufacturer. Filter by specialty or product code using the sidebar.

FDA 510(k) cleared devices by Okamoto USA, Inc.

14 devices
1-12 of 14
Cleared Feb 18, 2025
0.04 ZERO ZERO FOUR Male Latex Condom
K243584 · HIS
Obstetrics & Gynecology · 90d
Cleared Feb 25, 2022
Okamoto 002 Lubricated Polyurethane Male Condom
K203541 · MOL
Obstetrics & Gynecology · 449d
Cleared Jul 24, 2020
Extremely Thin 003, ZERO ZERO THREE
K192669 · HIS
Obstetrics & Gynecology · 303d
Cleared Jul 23, 2014
OKAMOTO STUDDED CONDOM
K141256 · HIS
Obstetrics & Gynecology · 70d
Cleared Jul 01, 2014
MEGA BIG BOY CONDOM
K140379 · HIS
Obstetrics & Gynecology · 137d
Cleared Mar 31, 2009
OKAMOTO ULTRA THIN
K090259 · HIS
Obstetrics & Gynecology · 57d
Cleared Aug 09, 1995
OKAMOTO CONDOM
K952393 · HIS
Obstetrics & Gynecology · 79d
Cleared Aug 13, 1990
EXTEND STABILITY DATE FOR CONDOM W/SPERM LUBRICANT
K902804 · HIS
Obstetrics & Gynecology · 47d
Cleared Jan 10, 1990
MODIFIED LABELING ON OKAMOTO HARMONY CONDOM
K896339 · HIS
Obstetrics & Gynecology · 68d
Cleared Mar 10, 1989
EXTRA STRENGTH SKIN LESS SKIN CONDOM
K884402 · HIS
Obstetrics & Gynecology · 142d
Cleared Jan 12, 1989
SKIN LESS SKIN CONDOM W/SPERMICIDAL LUBRICANT
K884401 · HIS
Obstetrics & Gynecology · 85d
Cleared Feb 26, 1988
RUBBER CONTRACEPTIVE, LATEX CONDOMS
K875111 · HIS
Obstetrics & Gynecology · 74d
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