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Disposable Biopsy Valve

FDA UDI

Class II (US FDA UDI)

by Zhejiang Chuangxiang Medical Technology Co., LTD.

Identity

Trade Name
Disposable Biopsy Valve FDA UDI
Generic Name
Endoscopic biopsy valve, sterile FDA UDI
Device Name
ClearGuard Disposable Biopsy Valve for Pentax GI Endoscopes FDA UDI
Model / Reference
MDBV1B0000A FDA UDI
Description
ClearGuard Disposable Biopsy Valve for Pentax GI Endoscopes FDA UDI

Identifiers

Catalog Number
000523 FDA UDI
Primary DI / UDI-DI
06970401812400 FDA UDI
510(k) Number
K173758 FDA UDI
FDA Product Code
OCX FDA UDI
GMDN Term
Endoscopic biopsy valve, sterile 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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Endoscopic biopsy valve, sterile

Disposable Biopsy Valve by Zhejiang Chuangxiang Medical Technology Co., LTD. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Endoscopic biopsy valve, sterile.

Cleared under the same submission

K173758 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zhejiang Chuangxiang Medical Technology Co., LTD.

Sources (1)

  • FDA UDI f7ff761b-0a5b-4587-acce-dbbc8c829003 35 fields · synced May 30, 2026