FDA.report

MINI Balloon Button

Primary DI
00842071146412
Brand
MINI Balloon Button
Company
APPLIED MEDICAL TECHNOLOGY, INC.
Model
5-1620
Catalog number
5-1620
Device description
16FR x 2.0 cm MINI Balloon Button Kit, MDR
Published
2026-02-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
KNTTubes, Gastrointestinal (And Accessories)

Product Code Classifications

CodeDeviceSpecialtyClass
KNTTubes, Gastrointestinal (And Accessories)Gastroenterology, Urology2

Premarket Submissions

SubmissionSupplement
K161413000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K161413000Low Profile Balloon Feeding DeviceApplied Medical Technology, Inc.2017-02-09KNT

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842071146412PrimaryGS10

GMDN Terms

TermDefinition
Gastrostomy buttonA sterile, short, hollow tube that is inserted into the stomach percutaneously to permit long-term enteral feeding. The tube does not permit reflux and its external end is flush with abdominal skin. This is a single-use device.

Device Sizes

TypeValueUnit
Catheter Gauge16French
Length2Centimeter

Sterilization Methods

Method

Contacts

PhoneEmail
(440)717-4000cs@appliedmedical.net

Regulatory Flags

DUNS number
038101861
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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00842071150037MiniSPC ButtonSPC-1417-12SPC-1417-122026-03-16
00842071150044MiniSPC ButtonSPC-1417-24SPC-1417-242026-03-16
00842071150051MiniSPC ButtonSPC-1420-12SPC-1420-122026-03-16
00842071150068MiniSPC ButtonSPC-1420-24SPC-1420-242026-03-16
00842071150075MiniSPC ButtonSPC-1423-12SPC-1423-122026-03-16
00842071150082MiniSPC ButtonSPC-1423-24SPC-1423-242026-03-16
00842071150099MiniSPC ButtonSPC-1425-12SPC-1425-122026-03-16
00842071150105MiniSPC ButtonSPC-1425-24SPC-1425-242026-03-16
00842071150112MiniSPC ButtonSPC-1427-12SPC-1427-122026-03-16

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