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endomina system

FDA UDI

Class II (US FDA UDI)

by Endo Tools Therapeutics

Identity

Trade Name
endomina system FDA UDI
Generic Name
Endoscopic overtube, single-use FDA UDI
Device Name
endomina system is composed of 1 endomina platform and 6 TAPES FDA UDI
Model / Reference
endomina system FDA UDI
Description
endomina system is composed of 1 endomina platform and 6 TAPES FDA UDI

Identifiers

Primary DI / UDI-DI
05425029282070 FDA UDI
510(k) Number
K211309 FDA UDI
FDA Product Code
OCW FDA UDI
GMDN Term
Endoscopic overtube, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Safe FDA UDI

Category: Suturing unit, single-useEndoscopic overtube, single-use

endomina system by Endo Tools Therapeutics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscopic overtube, single-use.

Cleared under the same submission

K211309 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Endo Tools Therapeutics

Sources (1)

  • FDA UDI b39e618f-d043-4da2-ba08-afb9a0016d0c 35 fields · synced Jun 1, 2026