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Endo Smartcap 100160

by Medivators Inc.

Ref 100160Model Endo Smartcap Tubing

Endo Smartcap 100160 is a device classified as Class IIa in the EU and Class II in the US made by Medivators Inc., registered in EUDAMED on 15 Sep 2026 (Basic UDI-DI B-00724995221317), cleared under FDA 510(k) K093665 on 15 Dec 2009 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 00724995221317), active as of 24 Oct 2026. 7 FDA recalls are linked to it.

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

CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None ongoing

7 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K093665

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00724995221317 Basic UDI-DI 00724995221317UDI-DIDate15 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00724995221317 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK093665 Date15 Dec 2009DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00724995221317 registered 15 Sep 2026 Active
  • FDA 510(k) K093665 decided 15 Dec 2009 Active
  • FDA GUDID UDI-DI 00724995221317 listed 22 Sep 2016 Listed

Recalls

7 recalls · FDA

  • 7 recalls, same reason

    • Terminated Z-1777-2020 FDA Class II initiated 9 Oct 2019
    • Terminated Z-1772-2020 FDA Class II initiated 9 Oct 2019
    • Terminated Z-1776-2020 FDA Class II initiated 9 Oct 2019
    • Terminated Z-1778-2020 FDA Class II initiated 9 Oct 2019
    • Terminated Z-1775-2020 FDA Class II initiated 9 Oct 2019
    • Terminated Z-1774-2020 FDA Class II initiated 9 Oct 2019
    • Terminated Z-1773-2020 FDA Class II initiated 9 Oct 2019

    Medivators is recalling Endo SmartCap Tubing due to a manufacturing anomaly that may present during procedures as inadequate insufflation, presence of air bubbles inside the endo smartcap tubing, insufficient water to rinse the endoscope lens, or water leaking from the air/water valve.

Timeline

10 dated events

  1. Cleared FDA 510(k) K093665
  2. Listed FDA GUDID 00724995221317
  3. Recall initiated FDA recalls Z-1777-2020
  4. Recall initiated FDA recalls Z-1772-2020
  5. Recall initiated FDA recalls Z-1776-2020
  6. Recall initiated FDA recalls Z-1778-2020
  7. Recall initiated FDA recalls Z-1775-2020
  8. Recall initiated FDA recalls Z-1774-2020
  9. Recall initiated FDA recalls Z-1773-2020
  10. Registered EUDAMED B-00724995221317

Coverage

2 jurisdictions

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

Specification

EUDAMED · GUDID

Trade name
Endo Smartcap
Generic name
Endoscopic insufflation tubing set, single-use
Device name
Endo Smartcap Tubing
Model / reference
100160, Endo Smartcap Tubing
Primary DI / UDI-DI
00724995221317 EUDAMED
00677964059551 GUDID
Basic UDI-DI
B-00724995221317
510(k) Number
FDA product code
FAJ
EMDN code
G020199 Gastrointestinal lavage, tubes and sets - other
GMDN term
Endoscopic insufflation tubing set, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Legacy device (under a directive)
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
00724995221317
GUDID
00677964059551
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 00724995221317; FDA GUDID lists 00677964059551), so their flags are not compared. Device class is stated on each registry's own scale: Class IIa 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 insufflation tubing set, single-use

Cleared under the same submission (K093665)

and 8 more cleared under K093665

Similar devices in this category

Other devices filed under GASTRO-INTESTINAL LAVAGE TUBES AND SETS.

Other devices from Medivators Inc.

See all devices from Medivators Inc. →

Properties

  • Supplied sterile
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)