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ClearCap Distal Attachment

FDA UDI

Class II (US FDA UDI)

by Finemedix Co., Ltd.

Identity

Trade Name
ClearCap Distal Attachment FDA UDI
Generic Name
Endoscope distal observation spacer, single-use FDA UDI
Device Name
12.4mm/10mm FDA UDI
Model / Reference
FM-EC0004 FDA UDI
Description
12.4mm/10mm FDA UDI

Identifiers

Primary DI / UDI-DI
08809327352838 FDA UDI
510(k) Number
K202616 FDA UDI
FDA Product Code
OCX FDA UDI
GMDN Term
Endoscope distal observation spacer, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1500 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Endoscope distal observation spacer, single-use

ClearCap Distal Attachment by Finemedix Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscope distal observation spacer, single-use.

Cleared under the same submission

K202616 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Finemedix Co., Ltd.

Sources (1)

  • FDA UDI 1dd47e3b-86b8-4e91-82a5-29b3e5743a0b 35 fields · synced Jun 6, 2026