Skip to content

Supercath 6

by Togo Medikit Co., Ltd.

510(k) K160592

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

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK160592 Date12 Aug 2016ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
FOZ
Device class
Class II
Regulation
21 CFR Part 880.5200
Advisory committee
General Hospital
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Supercath 6 is an intravascular catheter designed for vascular access procedures. It is intended for use in general hospital settings, providing reliable lumen patency for fluid administration, blood sampling, or hemodialysis.

This device is supplied as a single-use, sterile catheter and is classified under product code FOZ. It is intended for use in MRI environments, as indicated by its regulatory submission. The device received FDA 510(k) clearance under Traditional review, with a clearance date of 2016-08-12.

Other devices from Togo Medikit Co., Ltd.

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