FDA.reportPublic FDA data

NA

Primary DI
06959664922330
Brand
NA
Company
Hangzhou AGS MedTech Co., Ltd.
Model
AEU-120B
Published
2026-04-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNSUnit, Electrosurgical, Endoscopic (With Or Without Accessories)Gastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192342000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192342000Electrosurgical System (Electrosurgical Generator with Bipolar polypectomy snare combination and Single use electrosurgical knife combination accessories)Hangzhou AGS MedTech Co., Ltd.2020-05-21KNS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16959664922337PackageGS11In Commercial Distribution
06959664922330PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1695966492233716959664922337
06959664922330069596649223306959664922330

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical system generatorAn electrically-powered component of a electrosurgical system intended to generate radio-frequency (RF) electrical current for subsequent cutting and coagulation of soft tissues during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system generator). It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for inert gas-enhanced electrosurgery.

Regulatory Flags#

DUNS number
542984702
Device count
1
Serial number
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06959664913482NAAG-55501-1800-090-132026-07-16
06959664915387NAAG-55501-1650-090-112026-07-16
06959664915394NAAG-55501-1650-090-132026-07-16
06959664915400NAAG-55501-1650-090-162026-07-16
06959664915417NAAG-55501-1650-090-92026-07-16
06959664915424NAAG-55501-1650-135-112026-07-16
06959664915431NAAG-55501-1650-135-132026-07-16
06959664915448NAAG-55501-1650-135-162026-07-16
06959664915455NAAG-55501-1650-135-92026-07-16
06959664915462NAAG-55501-1950-090-112026-07-16
06959664915479NAAG-55501-1950-090-132026-07-16
06959664915493NAAG-55501-1950-090-92026-07-16
06959664915509NAAG-55501-1950-135-112026-07-16
06959664915516NAAG-55501-1950-135-132026-07-16
06959664915523NAAG-55501-1950-135-162026-07-16
06959664915530NAAG-55501-1950-135-92026-07-16
06959664915547NAAG-55501-2300-090-112026-07-16
06959664915554NAAG-55501-2300-090-132026-07-16
06959664915561NAAG-55501-2300-090-162026-07-16
06959664915578NAAG-55501-2300-090-92026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06932503516563Sphincterotome / short-wire compatibleMicro-Tech (Nanjing) Co., Ltd.KNS2026-06-27
00191506062620RIVOS™BOSTON SCIENTIFIC CORPORATIONKNS2026-06-25
08809909424502SphincterotomeTAEWOONGMEDICAL.CO.,LTDKNS2026-05-29
08809909424519SphincterotomeTAEWOONGMEDICAL.CO.,LTDKNS2026-05-29
08809909424526SphincterotomeTAEWOONGMEDICAL.CO.,LTDKNS2026-05-29
08809909424533SphincterotomeTAEWOONGMEDICAL.CO.,LTDKNS2026-05-29
08809909424540SphincterotomeTAEWOONGMEDICAL.CO.,LTDKNS2026-05-29
08809909424557SphincterotomeTAEWOONGMEDICAL.CO.,LTDKNS2026-05-29
08809909421709CystotomeTAEWOONGMEDICAL.CO.,LTDKNS2026-04-27
08809909421716CystotomeTAEWOONGMEDICAL.CO.,LTDKNS2026-04-27
08809909421693CystotomeTAEWOONGMEDICAL.CO.,LTDKNS2026-04-24
04545499074423SB Knife Jr2SB-KAWASUMI LABORATORIES, INC.KNS2026-04-06
04545499074430SB Knife Jr2 /Long typeSB-KAWASUMI LABORATORIES, INC.KNS2026-04-06
00827002613515SureTome SWCOOK INCORPORATEDKNS2025-12-08
00827002613522SureTome SWCOOK INCORPORATEDKNS2025-12-08
00827002597501Tesla BicordCOOK INCORPORATEDKNS2025-07-11
00724995226732Padlock ClipUS EndoscopyKNS2024-10-31
08809922260637ELRA ElectrodeSTARMED CO.,LTDKNS2024-08-28
04055207007822NARichard Wolf GmbHKNS2024-08-19
04055207008393NARichard Wolf GmbHKNS2024-08-19
04055207058985NARichard Wolf GmbHKNS2024-08-19
20653405051555APOLLO3Conmed CorporationKNS2024-07-22
20653405051562APOLLO3Conmed CorporationKNS2024-07-22
03665415002116Electrosurgical Unit MCBLAMIDEY NOURY MEDICALKNS2023-04-21
00851925007885Strauss SurgicalAMERICAN MEDICAL ENDOSCOPY, INC.KNS2023-03-08
06959664912126NAHangzhou AGS MedTech Co., Ltd.KNS2022-10-09
00884450329665Brighton™Merit Medical Systems, Inc.KNS2022-10-01
00884450502006Brighton™Merit Medical Systems, Inc.KNS2022-10-01
00884450502013Brighton™Merit Medical Systems, Inc.KNS2022-10-01
00884450502020Brighton™Merit Medical Systems, Inc.KNS2022-10-01