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CT-STOR

by Energy Delivery Solutions

510(k) K201789

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK201789 Date20 Sep 2021ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
NDS
Device Class
Class II
Regulation
21 CFR Part 876.5885
Advisory Committee
Gastroenterology, Urology
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.

CT-STOR is a media, culture, ex vivo, tissue and cell device classified under product code NDS and regulation number 876.5885. It is a Class II medical device with special controls, as determined by the FDA 510(k) clearance process.

The device was submitted by Energy Delivery Solutions and received FDA 510(k) clearance on September 20, 2021, under k-number K201789. It is intended for use in gastroenterology and urology applications, as indicated by the advisory committee assignment.

Questions

AI-generated answers, 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.

  • What is the CT-STOR device intended for?

    The CT-STOR device is intended for use in gastroenterology and urology applications, as indicated by its advisory committee assignment during the FDA 510(k) clearance process.

  • How was the CT-STOR device cleared for market?

    The CT-STOR device received FDA 510(k) clearance on September 20, 2021, under k-number K201789, following a traditional submission pathway and was found substantially equivalent to a predicate device.

  • What regulatory classification does the CT-STOR device have?

    The CT-STOR device is classified as a Class II medical device under product code NDS and regulation number 876.5885, with special controls applied as determined by the FDA.

  • Who manufactures the CT-STOR device and where are they located?

    The CT-STOR device is manufactured by Energy Delivery Solutions, located at 3315 Industrial Pkwy., Jeffersonville, IN 47130, United States.

  • What does the openFDA data tell us about the CT-STOR device?

    The openFDA data confirms the CT-STOR device is a Class II device named 'Media, Culture, Ex Vivo, Tissue And Cell' with FEI number 3016633010, regulation number 876.5885, and medical specialty descriptions in gastroenterology and urology.