FDA.reportPublic FDA data

ClearGrasp Snare

Primary DI
08809327351688
Brand
ClearGrasp Snare
Company
FINEMEDIX CO.,LTD.
Model
FM-ESN004(2400)(Soft)A
Device description
10mm/ Soft/ Oval/ Non-Rotation
Published
2019-04-12
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
FDISnare, Flexible

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FDISnare, FlexibleGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183289000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183289000ClearGrasp SnareFinemedix Co., Ltd.2019-03-06FDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18809327351685PackageGS110In Commercial Distribution
08809327351688PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880932735168518809327351685
08809327351688088093273516888809327351688

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
Serial number
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809327353293ClearHemograsperFM-HG0001(1820)FM-HG0001(1820)2026-03-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06936603211571Disposable Polypectomy SnareYangzhou Fartley Medical Instrument Technology Co., LtdFDI2026-10-25
06936603211588Disposable Polypectomy SnareYangzhou Fartley Medical Instrument Technology Co., LtdFDI2026-10-25
06936603211595Disposable Polypectomy SnareYangzhou Fartley Medical Instrument Technology Co., LtdFDI2026-10-25
06936603211618Disposable Polypectomy SnareYangzhou Fartley Medical Instrument Technology Co., LtdFDI2026-10-25
06936603211663Disposable Polypectomy SnareYangzhou Fartley Medical Instrument Technology Co., LtdFDI2026-10-25
06936603211670Disposable Polypectomy SnareYangzhou Fartley Medical Instrument Technology Co., LtdFDI2026-10-25
06936603211687Disposable Polypectomy SnareYangzhou Fartley Medical Instrument Technology Co., LtdFDI2026-10-25
06936603211694Disposable Polypectomy SnareYangzhou Fartley Medical Instrument Technology Co., LtdFDI2026-10-25
06936603211700Disposable Polypectomy SnareYangzhou Fartley Medical Instrument Technology Co., LtdFDI2026-10-25
06936603211731Disposable Polypectomy SnareYangzhou Fartley Medical Instrument Technology Co., LtdFDI2026-10-25
06936603211748Disposable Polypectomy SnareYangzhou Fartley Medical Instrument Technology Co., LtdFDI2026-10-25
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06936603211779Disposable Polypectomy SnareYangzhou Fartley Medical Instrument Technology Co., LtdFDI2026-10-25
06936603211724Disposable Polypectomy SnareYangzhou Fartley Medical Instrument Technology Co., LtdFDI2026-10-22
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