Supercath 5

by Togo Medikit Co., Ltd. 2 variants

510(k) K081953

Supercath 5 is a Class II device made by Togo Medikit Co., Ltd., cleared under FDA 510(k) K081953 on 12 Mar 2009, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K081953↗

FDA record

Trust

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK081953	Date12 Mar 2009Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K081953

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K081953
FDA product code: FOZ

Device class: Class II
Regulation: 21 CFR Part 880.5200
Advisory committee: General Hospital
FDA decision: SESE Substantially Equivalent

Other devices from Togo Medikit Co., Ltd.

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Supercath NEO

Class IIa
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Class IIa
Supercath PRO

Class IIa

See all devices from Togo Medikit Co., Ltd. →