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Guardus 00711148

by US Endoscopy

Ref 00711148Model Guardus Overtube - Non-sterile

Guardus 00711148 is a device classified as Class I in the EU and Class II in the US made by US Endoscopy, registered in EUDAMED on 22 Sep 2026 (Basic UDI-DI 0724995ENGUARDUSOTGNSG7), cleared under FDA 510(k) K040836 on 10 Jun 2004 and listed in FDA GUDID since 19 Mar 2020 (UDI-DI 00724995183639), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None, self-declared

Class I: no certifier involved

510(k) K040836

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0724995ENGUARDUSOTGNSG7 Basic UDI-DI 00724995183639UDI-DIDate22 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00724995183639 UDI-DI Date19 Mar 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK040836 Date10 Jun 2004DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0724995ENGUARDUSOTGNSG7 registered 22 Sep 2026 Active
  • FDA 510(k) K040836 decided 10 Jun 2004 Active
  • FDA GUDID UDI-DI 00724995183639 listed 19 Mar 2020 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

3 dated events

  1. Cleared FDA 510(k) K040836
  2. Listed FDA GUDID 00724995183639
  3. Registered EUDAMED 0724995ENGUARDUSOTGNSG7

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Guardus
Generic name
Endoscopic overtube, single-use
Device name
Guardus Overtube - Non-sterile
Model / Ref / Catalog
00711148, Guardus Overtube - Non-sterile
Primary DI / UDI-DI
00724995183639
Basic UDI-DI
0724995ENGUARDUSOTGNSG7
510(k) Number
FDA product code
FED
EMDN code
G0199 Oro-oesophageal tubes - other
GMDN term
Endoscopic overtube, single-use
Device class
Class I EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
Size
Outer Diameter — 19.5 Millimeter
Length — 50 Centimeter
Lumen/Inner Diameter — 17 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Endoscopic overtube, single-use

Cleared under the same submission (K040836)

and 2 more cleared under K040836

Similar devices in this category

Other devices filed under ORO-OESOPHAGEAL TUBES.

Other devices from US Endoscopy

See all devices from US Endoscopy →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (20, all answered No)