FDA.reportPublic FDA data

ClearCap Distal Attachment

Primary DI
18809327356154
Brand
ClearCap Distal Attachment
Company
FINEMEDIX CO.,LTD.
Model
FM-CC03
Catalog number
FM-CC03
Device description
Conical Cap Ø11.35mm
Published
2026-03-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
18809327356154PackageGS110In Commercial Distribution
08809327356157PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880932735615418809327356154
08809327356157088093273561578809327356157

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.

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
false
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
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
08809327356195ClearCap Distal AttachmentFINEMEDIX CO.,LTD.OCX2026-03-24
M84921890CleanCapture Aspiration CatheterHOBBS MEDICAL, INC.OCX2026-01-14
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14953170458429SINGLE USE BIOPSY VALVEOLYMPUS MEDICAL SYSTEMS CORP.OCX2025-09-30
00724995232177Fuji 700 4-piece Valve KitUS EndoscopyOCX2025-05-29
00850025860901CO2 Source Tubing Filter Adapter OlympusMicro-tech UsaOCX2025-05-12
00858276007977CO2 Source Tubing Filter OlympusMicro-tech UsaOCX2025-05-12
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