Flexible Video-Choledo-Cysto-Ureteroscope

FDA UDI

Class II (US FDA UDI)

by Shanghai SeeGen Photoelectric Technology Co., Ltd

Identity

Trade Name: Flexible Video-Choledo-Cysto-Ureteroscope FDA UDI
Generic Name: Flexible video ureteroscope, single-use FDA UDI
Model / Reference: UV-US100-H(STD) FDA UDI

Identifiers

Primary DI / UDI-DI: 06973786291396 FDA UDI
510(k) Number: K211686 FDA UDI
FDA Product Code: FBN FDA UDI
GMDN Term: Flexible video ureteroscope, 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

FDA UDI

Contains Latex

FDA UDI

Prescription Use

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Flexible video ureteroscope, single-use

Flexible Video-Choledo-Cysto-Ureteroscope by Shanghai SeeGen Photoelectric Technology Co., Ltd — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Flexible video ureteroscope, single-use.

Single-use Flexible Uretero-Renoscope — Zhuhai Vision Medical Technology Co., Ltd · Class IIa
Ureterorenoscope — Innoview GmbH · Class IIa
WiScope® — OTU MEDICAL INC. · Class II
URS. 040.00.1500 — Blazejewski MEDI-TECH GmbH · Class IIa
CoralView® — MacroLux Medical Technology Co., Ltd. · Class II
LithoVue — Boston Scientific · Class II
Single-use Digital Flexible Ureterorenoscopes — NINGBO XINWELL MEDICAL TECHNOLOGY CO., LTD. · Class IIa
Flexible Ureterorenoscopes — Shanghai Anqing Medical Instrument Co., Ltd · Class IIa

Cleared under the same submission

K211686 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: Shanghai SeeGen Photoelectric Technology Co., Ltd

Sources (1)

FDA UDI fd66ef9a-8b61-48ae-8518-df2d07bd29a1 33 fields · synced May 30, 2026