Medical Device Manufacturer · US , Stratford , CT

Okamoto USA, Inc.

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

Okamoto USA, Inc. — FDA 510(k) Submissions

Okamoto USA, Inc. has submitted 14 FDA 510(k) premarket notifications since 1987, of which 14 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Condom, Condom, Synthetic . Use the specialty filter in the sidebar to narrow results.

14 devices
1–14 of 14
0.04 ZERO ZERO FOUR Male Latex Condom
K243584 · HIS Condom · Obstetrics & Gynecology
Feb 2025 90d
Okamoto 002 Lubricated Polyurethane Male Condom
K203541 · MOL Condom, Synthetic · Obstetrics & Gynecology
Feb 2022 449d
Extremely Thin 003, ZERO ZERO THREE
K192669 · HIS Condom · Obstetrics & Gynecology
Jul 2020 303d
OKAMOTO STUDDED CONDOM
K141256 · HIS Condom · Obstetrics & Gynecology
Jul 2014 70d
MEGA BIG BOY CONDOM
K140379 · HIS Condom · Obstetrics & Gynecology
Jul 2014 137d
OKAMOTO ULTRA THIN
K090259 · HIS Condom · Obstetrics & Gynecology
Mar 2009 57d
OKAMOTO CONDOM
K952393 · HIS Condom · Obstetrics & Gynecology
Aug 1995 79d
EXTEND STABILITY DATE FOR CONDOM W/SPERM LUBRICANT
K902804 · HIS Condom · Obstetrics & Gynecology
Aug 1990 47d
MODIFIED LABELING ON OKAMOTO HARMONY CONDOM
K896339 · HIS Condom · Obstetrics & Gynecology
Jan 1990 68d
EXTRA STRENGTH SKIN LESS SKIN CONDOM
K884402 · HIS Condom · Obstetrics & Gynecology
Mar 1989 142d
SKIN LESS SKIN CONDOM W/SPERMICIDAL LUBRICANT
K884401 · HIS Condom · Obstetrics & Gynecology
Jan 1989 85d
RUBBER CONTRACEPTIVE, LATEX CONDOMS
K875111 · HIS Condom · Obstetrics & Gynecology
Feb 1988 74d
SKINLESS SKIN-HARMONY CONDOMS
K872664 · HIS Condom · Obstetrics & Gynecology
Nov 1987 120d
SKINLESS-SKIN, PINK TINT (CONDOM)
K872812 · HIS Condom · Obstetrics & Gynecology
Nov 1987 112d
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