FDA.reportPublic FDA data

ClearEndoclip

Primary DI
18809327353092
Brand
ClearEndoclip
Company
FINEMEDIX CO.,LTD.
Model
FM-CLD11-090(2300)
Device description
11mm/90°/2300mm
Published
2020-10-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PKLHemostatic Metal Clip For The Gi Tract

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PKLHemostatic Metal Clip For The Gi TractGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200217000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200217000ClearEndoclipFinemedix Co., Ltd.2020-10-05PKL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18809327353092PackageGS15In Commercial Distribution
08809327353095PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880932735309218809327353092
08809327353095088093273530958809327353095

GMDN Terms#

Term, Definition table
TermDefinition
Gastrointestinal endoscopic clip, short-termA sterile clip intended to be placed short-term (<=30 days) within the gastrointestinal (GI) tract during an endoscopic procedure for endoscopic marking, haemostasis, tissue approximation, closure of luminal perforations, and/or for treating mucosal/submucosal defects. It is a metallic device with a clasping mechanism; a disposable applicator may be included. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
688256864
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
06959664915868NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664915875NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664915882NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664915899NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664915912NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664915936NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664915943NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664915950NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664915967NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664915974NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664915981NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916094NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916100NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916117NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916124NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916131NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916292NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916308NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916315NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916322NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916339NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916346NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916353NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916360NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916490NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916506NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916513NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916520NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916537NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23
06959664916698NAHangzhou AGS MedTech Co., Ltd.PKL2026-07-23