FDA.reportPublic FDA data

NA

Primary DI
06959664913871
Brand
NA
Company
Hangzhou AGS MedTech Co., Ltd.
Model
AG-5461-0516
Published
2026-04-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KGEForceps, Biopsy, Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGEForceps, Biopsy, ElectricGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210406000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210406000Bipolar Coagulation ForecepsHangzhou AGS MedTech Co., Ltd.2021-10-05KGE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16959664913878PackageGS15In Commercial Distribution
26959664913875PackageGS110In Commercial Distribution
06959664913871PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1695966491387816959664913878
2695966491387526959664913875
06959664913871069596649138716959664913871

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, bipolar, single-useA sterile electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a bipolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery, and may in addition be intended for open surgery; it is not intended for focal percutaneous ablation. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps, rigid probe with controls). This is a single-use device.

Regulatory Flags#

DUNS number
542984702
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06959664900086NAAG-51061-1650-090-92026-08-19
06959664900178NAAG-51061-1800-090-92026-08-19
06959664900185NAAG-51061-1950-090-92026-08-19
06959664900192NAAG-51061-2150-090-92026-08-19
06959664900291NAAG-51061-2300-090-92026-08-19
06959664900307NAAG-51061-1650-135-92026-08-19
06959664900314NAAG-51061-1800-135-92026-08-19
06959664900543NAAG-51061-1950-135-92026-08-19
06959664900550NAAG-51061-2150-135-92026-08-19
06959664900574NAAG-51061-2300-135-92026-08-19
06959664900598NAAG-51063-1650-090-132026-08-19
06959664900635NAAG-51063-1800-090-132026-08-19
06959664900666NAAG-51063-1950-090-132026-08-19
06959664900697NAAG-51063-1950-090-132026-08-19
06959664900840NAAG-51063-1950-090-132026-08-19
06959664900864NAAG-51063-1650-135-132026-08-19
06959664900871NAAG-51063-1800-135-132026-08-19
06959664900888NAAG-51063-1950-135-132026-08-19
06959664900895NAAG-51063-2150-135-132026-08-19
06959664900901NAAG-51063-2300-135-132026-08-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06959664913888NAHangzhou AGS MedTech Co., Ltd.KGE2026-04-15
06959664913895NAHangzhou AGS MedTech Co., Ltd.KGE2026-04-15
06959664913901NAHangzhou AGS MedTech Co., Ltd.KGE2026-04-15
06959664913918NAHangzhou AGS MedTech Co., Ltd.KGE2026-04-15
06959664913925NAHangzhou AGS MedTech Co., Ltd.KGE2026-04-15
06959664913932NAHangzhou AGS MedTech Co., Ltd.KGE2026-04-15
06959664913949NAHangzhou AGS MedTech Co., Ltd.KGE2026-04-15
06959664913956NAHangzhou AGS MedTech Co., Ltd.KGE2026-04-15
06959664913963NAHangzhou AGS MedTech Co., Ltd.KGE2026-04-15
06959664913970NAHangzhou AGS MedTech Co., Ltd.KGE2026-04-15
06959664913987NAHangzhou AGS MedTech Co., Ltd.KGE2026-04-15
04953170466038Single Use Electrosurgical Hemostatic ForcepsOLYMPUS MEDICAL SYSTEMS CORP.KGE2026-04-01
04953170466182Single Use Electrosurgical Hemostatic ForcepsOLYMPUS MEDICAL SYSTEMS CORP.KGE2026-04-01
04953170466267Single Use Electrosurgical Hemostatic ForcepsOLYMPUS MEDICAL SYSTEMS CORP.KGE2026-04-01
08809327353293ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
08809327353316ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
08809327353323ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
08809327355518ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
08809327355808ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
18809327353290ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
18809327353313ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
18809327353320ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
18809327355515ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
18809327355805ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
04953170466243DISPOSABLE HOT BIOPSY FORCEPSOLYMPUS MEDICAL SYSTEMS CORP.KGE2025-11-19
04953170466250DISPOSABLE HOT BIOPSY FORCEPSOLYMPUS MEDICAL SYSTEMS CORP.KGE2025-11-19
06934415022309ZKSKBeijing ZKSK Technology Co.,LtdKGE2023-12-19
06934415022316ZKSKBeijing ZKSK Technology Co.,LtdKGE2023-12-19
06934415022323ZKSKBeijing ZKSK Technology Co.,LtdKGE2023-12-19
06934415022347ZKSKBeijing ZKSK Technology Co.,LtdKGE2023-12-19