Jacket Biopsy Valve

FDA UDI

Class II (US FDA UDI)

by Micro-tech Usa

Identity

Trade Name: Jacket Biopsy Valve FDA UDI
Generic Name: Endoscope working-channel valve, single-use FDA UDI
Device Name: Jacket Disp Biopsy Valve Olym/Fuji FDA UDI
Model / Reference: MD-A-BV02 FDA UDI
Description: Jacket Disp Biopsy Valve Olym/Fuji FDA UDI

Identifiers

Primary DI / UDI-DI: 00858276007243 FDA UDI
510(k) Number: K173758 FDA UDI
FDA Product Code: OCX FDA UDI
GMDN Term: Endoscope working-channel valve, 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Endoscope working-channel valve, single-use

Jacket Biopsy Valve by Micro-tech Usa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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SINGLE USE BIOPSY VALVE (Sterile) — Olympus Medical Systems Corporation · Class II

Cleared under the same submission

K173758 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Micro-tech Usa

Sources (1)

FDA UDI 0491e1d8-afa0-40f7-9205-fdf773057eee 34 fields · synced May 30, 2026