OTU Medical Inc

FDA Device Registration & Listing · Union City, CA, US · Registration 3013992977

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013992977
FEI Number
3013992977
Entity Name
OTU Medical Inc
City/State/Country
Union City, CA, US
Establishment Address
2847A Whipple Rd., Union City, CA 94587, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
OTU MEDICAL INC. (Owner Number: 10058788)
Owner / Operator Contact Address
2847 Whipple Rd., Ste. A, Union City, CA 94587, Union City, CA 94587, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K212202
PMA Number
N/A

All Registered Proprietary Names

WiScope Digital Bronchoscope System WiScope® Single-Use Digital Flexible Bronchoscope WiScope® Image System WiScope® Single-Use Digital Flexible Cystoscope WiScope® Digital Cystoscope System WiScope® Image System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2021-08-05
FBN Choledochoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2021-08-05
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2022-11-18
FAJ Cystoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2022-04-15

Official Correspondent

GEPING LIU

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OTU MEDICAL INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K915458 Psi Medical Products, Inc. URETEROSCOPE 1992-01-30
K811059 Pentax Precision Instrument Corp. PENTAX BRONCHOFIBERSCOPE #FB-15A 1981-05-27
K142934 Covidien CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved 2015-06-17
K240075 FUJIFILM Healthcare Americas Corporation FUJIFILM Endoscope Model EB-710XT 2024-02-07

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0025-2020 AURIS HEALTH INC 2
Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120

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1000121056 Boston Scientific Corporation Coventry, RI, US
3010202439 Karl Storz Endoscopy-America, Inc. El Segundo, CA, US
3005099803 BOSTON SCIENTIFIC CORPORATION Marlborough, MA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013992977. Last updated year: 2026. Please use registration number 3013992977 when referencing this establishment in official correspondence.
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