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AMT Mini™ Balloon Button 5-1823-I

by Applied Medical Technology, Inc.

Ref 5-1823-I

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 2 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K161413

+1 more

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 2 Nov 2026. What this means

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08420711BALLOONBUTTON7U Basic UDI-DI 00842071146689UDI-DIDate22 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00842071146689 UDI-DI Date18 Apr 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK161413 Date9 Feb 2017DecidedStatusActive

Official records

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 2 Nov 2026.

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  • Withdrawn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
MINI™ Balloon Button - Low Profile Gastrostomy Feeding Tube EUDAMED
AMT Mini™ Balloon Button GUDID
MINI Balloon Button GUDID
Generic name
Gastrostomy button
Device name
Low Profile Balloon Button
Model / Ref / Catalog
5-1823-I
Primary DI / UDI-DI
00842071146689, 00842071123925
Basic UDI-DI
08420711BALLOONBUTTON7U
510(k) Number
FDA product code
KNT
EMDN code
G02020201 Gastrostomy, tubes and sets
GMDN term
Gastrostomy button
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.5980
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional
Size
Length — 2.3 Centimeter
Catheter Gauge — 18 French

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Gastrostomy button

Cleared under the same submission (K945618)

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Other devices from Applied Medical Technology, Inc.

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Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date NoGUDIDYesGUDID

Other properties (17)

  • Sterilise before use: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Over-the-counter: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No