endomina system

by Endo Tools Therapeutics

endomina system is a Class II device made by Endo Tools Therapeutics, cleared under FDA 510(k) K211309 on 7 Dec 2021 and listed in FDA GUDID since 19 Jul 2022 (UDI-DI 05425029282070), active as of 1 Jun 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 1 Jun 2026

Documents

FDA submission, from GUDID

Trust

Source GUDID, synced 1 Jun 2026.

Regulatory status

as of registry sync 1 Jun 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number05425029282070 UDI-DI	Date19 Jul 2022Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK211309	Date7 Dec 2021Decided	StatusActive

Official records

AccessGUDID record UDI-DI 05425029282070
FDA 510(k) database 510(k) number K211309

Across registries

2 registries list this device

FDA 510(k) K211309 decided 7 Dec 2021 Active
FDA GUDID UDI-DI 05425029282070 listed 19 Jul 2022 Listed

Timeline

2 dated events

7 Dec 2021 Cleared FDA 510(k) K211309
19 Jul 2022 Listed FDA GUDID 05425029282070

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name: Endoscopic overtube, single-use
Model / reference: endomina system

Primary DI / UDI-DI: 05425029282070
510(k) Number: K211309
FDA product code: OCW
GMDN term: Endoscopic overtube, single-use

Device class: Class II
Regulation number: 876.1500
GUDID distribution status: In Commercial Distribution

MRI safety: MR Safe

Similar devices in this category

Other devices filed under Endoscopic overtube, single-use.

Other devices from Endo Tools Therapeutics

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endomina EZFuse system

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Tapes

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endomina platform

Class II

Properties

Supplied sterile
Single use
Prescription use
Convenience kit

Other properties (11, all answered No)