FDA.reportPublic FDA data

ClearCap Distal Attachment

Primary DI
08809327356195
Brand
ClearCap Distal Attachment
Company
FINEMEDIX CO.,LTD.
Model
FM-CC07
Catalog number
FM-CC07
Device description
Conical Cap Ø15.7mm
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
OCXEndoscopic Irrigation/Suction System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OCXEndoscopic Irrigation/Suction SystemGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242134000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242134000ClearCap Distal AttachmentFinemedix Co., Ltd.2024-08-20OCX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18809327356192PackageGS110In Commercial Distribution
08809327356195PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880932735619218809327356192
08809327356195088093273561958809327356195

GMDN Terms#

Term, Definition table
TermDefinition
Endoscope distal observation spacer, single-useA short, light-penetrating cap designed to be placed onto the distal end of an endoscope (e.g., colonoscope) to facilitate observation, by retaining a short distance between the endoscope tip and lumen wall or other structure of interest. It typically has a small hole to allow fluid drain from inside the cap; it does not have anchoring capabilities (i.e., not an anchoring cuff). 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
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
08809327356133ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356140ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356157ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356164ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356171ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
08809327356188ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
M84921890CleanCapture Aspiration CatheterHOBBS MEDICAL, INC.OCX2026-01-14
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00724995232177Fuji 700 4-piece Valve KitUS EndoscopyOCX2025-05-29
00850025860901CO2 Source Tubing Filter Adapter OlympusMicro-tech UsaOCX2025-05-12
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00850025860420Irrigation Tubing SetMicro-tech UsaOCX2025-03-07
00850025860390Air/Water Bottle CO2 TubingMicro-tech UsaOCX2025-03-04
00850025860451Air/Water Bottle TubingMicro-tech UsaOCX2025-03-04
00850025860772Air/Water Bottle TubingMicro-tech UsaOCX2025-03-04
00850025860789Air/Water Bottle CO2 TubingMicro-tech UsaOCX2025-03-04
00850025860796Irrigation Tubing SetMicro-tech UsaOCX2025-03-04
00850025860840Irrigation Tubing SetMicro-tech UsaOCX2025-03-04
00850025860307A/W Channel Cleaning Adapter + 4-Piece Valve KitMicro-tech UsaOCX2025-03-03
008500258603694-Piece Valve KitMicro-tech UsaOCX2025-03-03
008500258605813-Piece Valve KitMicro-tech UsaOCX2025-03-03
00858276007243Jacket Biopsy ValveMicro-tech UsaOCX2025-03-03
00858276007335Jacket Biopsy ValveMicro-tech UsaOCX2025-03-03
M78312011110Diversatek HealthcareDIVERSATEK HEALTHCARE, INC.OCX2025-01-10
03700506320264ELUXEO Tubing KitNISSHA MEDICAL TECHNOLOGIES SASOCX2024-09-02
03700506320271ELUXEO Tubing KitNISSHA MEDICAL TECHNOLOGIES SASOCX2024-09-02
03700506320288ELUXEO TubingNISSHA MEDICAL TECHNOLOGIES SASOCX2024-09-02
03700506320295ELUXEO TubingNISSHA MEDICAL TECHNOLOGIES SASOCX2024-09-02
03700506320301ELUXEO TubingNISSHA MEDICAL TECHNOLOGIES SASOCX2024-09-02