FDA.reportPublic FDA data

NA

Primary DI
16959664910754
Brand
NA
Company
Hangzhou AGS MedTech Co., Ltd.
Model
AG-5453-13-15-18
Published
2022-10-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GCABiliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCABiliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast InjectionGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200173000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200173000Stone Retrieval BalloonHangzhou AGS MedTech Co., Ltd.2020-05-01GCA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16959664910754PackageGS15In Commercial Distribution
26959664910751PackageGS150In Commercial Distribution
06959664910757PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1695966491075416959664910754
2695966491075126959664910751
06959664910757069596649107576959664910757

GMDN Terms#

Term, Definition table
TermDefinition
ERCP catheter, balloon, non-electrical, stone-retrievalA flexible, tubular, non-electrical device with an inflatable multi-sizing balloon at the distal end designed for the removal of stones (calculi) from the biliary tract during endoscopic retrograde cholangiopancreatography (ERCP). It is inserted through the working channel of an endoscope, typically beyond the stones, where the balloon is inflated and retracted to push the stones out. It typically has more than one lumen to allow, e.g., use of a guidewire while simultaneously enabling the injection of a contrast medium into the biliary tree for fluoroscopic visualization of the bile ducts. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
542984702
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06959664905203NAAG-50114-23122026-05-15
06959664905210NAAG-50114-23162026-05-15
06959664905227NAAG-50114-23182026-05-15
06959664905234NAAG-50114-23202026-05-15
06959664905241NAAG-50114-23232026-05-15
06959664905258NAAG-50114-23272026-05-15
06959664905265NAAG-50115-23072026-05-15
06959664905272NAAG-50115-23122026-05-15
06959664905289NAAG-50115-23162026-05-15
06959664905296NAAG-50115-23182026-05-15
06959664905302NAAG-50115-23202026-05-15
06959664905319NAAG-50115-23232026-05-15
06959664905326NAAG-50115-23272026-05-15
06959664905333NAAG-50115-18072026-05-15
06959664905340NAAG-50115-18122026-05-15
06959664905357NAAG-50115-18162026-05-15
06959664905364NAAG-50115-18182026-05-15
06959664905371NAAG-50115-18202026-05-15
06959664905388NAAG-50115-18232026-05-15
06959664905395NAAG-50115-18272026-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06970057571027Stone Extraction BalloonJiangsu Vedkang Medical Science and Technology Co.,Ltd.GCA2026-04-14
06948318963102AnreiAnrei Medical(HZ) Co.,Ltd.GCA2025-01-07
06948318963119AnreiAnrei Medical(HZ) Co.,Ltd.GCA2025-01-07
04711182608309Silicone T Drainage Set With EyesFORTUNE MEDICAL INSTRUMENT CORP.GCA2023-10-24
04711182608316Silicone T Drainage Set With EyesFORTUNE MEDICAL INSTRUMENT CORP.GCA2023-10-24
14711182608306Silicone T Drainage Set With EyesFORTUNE MEDICAL INSTRUMENT CORP.GCA2023-10-24
14711182608313Silicone T Drainage Set With EyesFORTUNE MEDICAL INSTRUMENT CORP.GCA2023-10-24
06959664910702NAHangzhou AGS MedTech Co., Ltd.GCA2022-10-09
06959664910719NAHangzhou AGS MedTech Co., Ltd.GCA2022-10-09
06959664910740NAHangzhou AGS MedTech Co., Ltd.GCA2022-10-09
06959664910757NAHangzhou AGS MedTech Co., Ltd.GCA2022-10-09
16959664910709NAHangzhou AGS MedTech Co., Ltd.GCA2022-10-09
16959664910716NAHangzhou AGS MedTech Co., Ltd.GCA2022-10-09
16959664910747NAHangzhou AGS MedTech Co., Ltd.GCA2022-10-09
00191506013493SpyGlass™ DiscoverBOSTON SCIENTIFIC CORPORATIONGCA2022-06-03
00191506013509SpyGlass™ DiscoverBOSTON SCIENTIFIC CORPORATIONGCA2022-06-03
00191506013516SpyGlass™ DiscoverBOSTON SCIENTIFIC CORPORATIONGCA2022-06-03
10195594641436CARDINAL HEALTHCardinal Health 200, LLCGCA2022-04-12
50195594641434CARDINAL HEALTHCardinal Health 200, LLCGCA2022-04-12
10827002588032AdvanceCOOK INCORPORATEDGCA2021-02-09
10827002588049AdvanceCOOK INCORPORATEDGCA2021-02-09
00690103205114FOGARTYEdwards Lifesciences LLCGCA2020-08-31
00690103205121FOGARTYEdwards Lifesciences LLCGCA2020-08-31
00690103205138FOGARTYEdwards Lifesciences LLCGCA2020-08-31
50690103205119FOGARTYEdwards Lifesciences LLCGCA2020-08-31
50690103205126FOGARTYEdwards Lifesciences LLCGCA2020-08-31
50690103205133FOGARTYEdwards Lifesciences LLCGCA2020-08-31
00816349011696TaxiLake Region MedicalGCA2018-11-27
04711182607548Silicone T Drainage Set With EyesFORTUNE MEDICAL INSTRUMENT CORP.GCA2017-08-15
00816349011436AnchorwireLake Region MedicalGCA2017-01-25