Skip to content

Super Sheath

by Togo Medikit Co., Ltd.

510(k) K200379

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 · Special NumberK200379 Date19 Mar 2020ClearedStatusActive

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  • Withdrawn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
DRE
Device class
Class II
Regulation
21 CFR Part 870.1310
Advisory committee
Cardiovascular
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Super Sheath is a percutaneous catheterization dilator and introducer sheath designed to facilitate vascular access. It features a funnel-shaped dilator and a smooth tip to assist with entry and reduce trauma during clinical procedures.

These devices are provided sterile and are intended for single-procedure use only. They are available in diameters ranging from 4F to 9F and lengths between 7 cm and 25 cm, with some models including suture wings or radiopaque markers. This device is authorized under FDA 510(k) clearance.

Other devices from Togo Medikit Co., Ltd.

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

Questions

AI-generated answers, 25 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 intended use of the Super Sheath?

    The Super Sheath is designed to facilitate vascular access during percutaneous catheterization procedures. It includes a funnel-shaped dilator and a smooth tip to assist with entry and minimize trauma to the patient.

  • Are these devices provided sterile and can they be reused?

    The devices are provided sterile and are intended for single-procedure use only. They should not be reused to ensure patient safety and maintain the integrity of the sterile barrier.

  • What size options are available for this device?

    The Super Sheath is available in a range of diameters from 4F to 9F and lengths between 7 cm and 25 cm to accommodate different clinical requirements.

  • Does the device include any additional features for clinical use?

    Yes, some models of the Super Sheath are equipped with suture wings for secure placement or radiopaque markers to assist with visualization during procedures.