FDA.reportPublic FDA data

ClearHemograsper

Primary DI
08809327353293
Brand
ClearHemograsper
Company
FINEMEDIX CO.,LTD.
Model
FM-HG0001(1820)
Catalog number
FM-HG0001(1820)
Device description
5mm/ 1,820mm
Published
2026-03-24
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

Contact Domains#

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
K242857000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242857000ClearHemograsperFinemedix Co., Ltd.2025-05-21KGE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18809327353290PackageGS15In Commercial Distribution
08809327353293PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880932735329018809327353290
08809327353293088093273532938809327353293

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical electrode, monopolar, single-useA sterile, invasive, distal component of an electrosurgical assembly intended to deliver electrosurgical current in a monopolar configuration (i.e., used with a patient contact return electrode) to tissues for cutting/coagulation/ablation during endoscopic (e.g., laparoscopic, arthroscopic) surgery. It is available in a variety of forms (e.g., exchangeable electrode for electrosurgical forceps, rigid electrode, flexible endoscopic probe) which may include a lumen for suction/irrigation. It does not include a handpiece or housing and has no electrical or mechanical controls (e.g., does not include ring-handles); it is not intended for gas-enhanced electrosurgery. This is a single-use device.

Contacts#

Phone, Email table
PhoneEmail
+82537418388finemedix@finemedix.com

Regulatory Flags#

DUNS number
688256864
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809327353316ClearHemograsperFM-HG0001(1650)FM-HG0001(1650)2026-03-24
08809327353323ClearHemograsperFM-HG0001(2000)FM-HG0001(2000)2026-03-24
08809327353415ClearTipFM-CTA004FM-CTA0042026-03-24
08809327355518ClearHemograsperFM-HG0001(2300)BFM-HG0001(2300)B2026-03-24
08809327355532ClearTipFM-CTA004CFM-CTA004C2026-03-24
08809327355549ClearTipFM-CTA004NOFM-CTA004NO2026-03-24
08809327355556ClearTipFM-CTA004NPFM-CTA004NP2026-03-24
08809327355563ClearTipFM-CTA004NCOFM-CTA004NCO2026-03-24
08809327355570ClearTipFM-CTA004NCPFM-CTA004NCP2026-03-24
08809327355808ClearHemograsperFM-HG0001(1820)BFM-HG0001(1820)B2026-03-24
08809327355969ClearTipFM-CTB012FM-CTB0122026-03-24
08809327355976ClearTipFM-CTA012NFM-CTA012N2026-03-24
08809327355983ClearTipFM-CTA002FFM-CTA002F2026-03-24
08809327355990ClearTipFM-CTA012FM-CTA0122026-03-24
08809327356003ClearTipFM-CTA011NFM-CTA011N2026-03-24
08809327356010ClearTipFM-CTA013NFM-CTA013N2026-03-24
08809327356027ClearTipFM-CTB012NFM-CTB012N2026-03-24
08809327356034ClearTipFM-CTB011NFM-CTB011N2026-03-24
08809327356041ClearTipFM-CTB013NFM-CTB013N2026-03-24
08809327356058ClearTipFM-CTB011FM-CTB0112026-03-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06959664913871NAHangzhou AGS MedTech Co., Ltd.KGE2026-04-15
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
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