Skip to content

Supercath V

by Togo Medikit Co., Ltd.

510(k) K052267

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 NumberK052267 Date27 Oct 2006ClearedStatusActive

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  • Withdrawn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
FIE
Device class
Class II
Regulation
21 CFR Part 876.5540
Advisory committee
Gastroenterology, Urology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 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 V is a needle device classified under product code FIE for use in gastroenterology and urology procedures. It is designed for specific medical applications related to fistula management.

The device is supplied as a single-use product and is not indicated for MRI use. It is stored according to manufacturer guidelines and has received FDA 510(k) clearance with registration number 8041145.

Other devices from Togo Medikit Co., Ltd.

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

Questions

AI-generated answers, 21 Sep 2026

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

  • What is the Supercath V device used for?

    The Supercath V is a needle device designed for specific medical applications related to fistula management in gastroenterology and urology procedures. It is not indicated for MRI use.

  • Is the Supercath V reusable or single-use?

    The Supercath V is supplied as a single-use product and should not be reused according to manufacturer guidelines. This ensures patient safety and device performance.

  • What regulatory approvals does the Supercath V have?

    The Supercath V has received FDA 510(k) clearance with registration number 8041145. It is classified under product code FIE and is substantially equivalent to predicate devices for gastroenterology and urology procedures.

  • How should the Supercath V be stored?

    The Supercath V should be stored according to the manufacturer's guidelines to maintain its integrity and functionality. Specific storage conditions are not detailed in the provided information.