WiScope®

FDA UDI

Class II (US FDA UDI)

by Otu Medical Inc.

Identity

Trade Name: WiScope® FDA UDI
Generic Name: Flexible video ureteroscope, single-use FDA UDI
Device Name: Single-Use Digital Flexible UroScope FDA UDI
Model / Reference: OTU-C380SR FDA UDI
Description: Single-Use Digital Flexible UroScope FDA UDI

Identifiers

Catalog Number: 4102C0401T FDA UDI
Primary DI / UDI-DI: 00850023925152 FDA UDI
510(k) Number: K181977 FDA UDI
FDA Product Code: FGB 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

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

FDA UDI

Category: Flexible video ureteroscope, single-use

WiScope® by Otu Medical Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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
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
SEPLOU — Seplou (Zhuhai) Co., Ltd. · Class II

Cleared under the same submission

K181977 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: Otu Medical Inc.

Sources (1)

FDA UDI f35fee76-3351-4181-a5c8-48104130df5f 35 fields · synced Jun 1, 2026