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Single-use Broncho Videoscope

FDA UDI

Class II (US FDA UDI)

by Scivita Medical Technology Co., Ltd.

Identity

Trade Name
Single-use Broncho Videoscope FDA UDI
Generic Name
Flexible video bronchoscope, single-use FDA UDI
Device Name
The product is composed of a distal end, a bending section, an insertion section, an operation section, and a plug section. This Single-use Broncho Videoscope is intended to use in conjunction with Endoscopic Image Processor to provide images through the video monitor for observation, diagnosis, photography and treatment of respiratory system such as trachea, bronchi, and lungs. FDA UDI
Model / Reference
SBV-1A-P FDA UDI
Description
The product is composed of a distal end, a bending section, an insertion section, an operation section, and a plug section. This Single-use Broncho Videoscope is intended to use in conjunction with Endoscopic Image Processor to provide images through the video monitor for observation, diagnosis, photography and treatment of respiratory system such as trachea, bronchi, and lungs. FDA UDI

Identifiers

Primary DI / UDI-DI
06971381252347 FDA UDI
510(k) Number
K210379 FDA UDI
FDA Product Code
EOQ FDA UDI
GMDN Term
Flexible video bronchoscope, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
874.4680 FDA UDI
Commercial Distribution
Not 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

Yes

FDA UDI

Single-use Broncho Videoscope by Scivita Medical Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K210379 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Scivita Medical Technology Co., Ltd.

Sources (1)

  • FDA UDI c7ffab2e-1cb6-498a-b51a-8562f43f8af8 36 fields · synced May 30, 2026