Auris Health, Inc

FDA Device Registration & Listing · Santa Clara, CA, US · Registration 3017425975

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
3017425975
FEI Number
3014447948
Entity Name
Auris Health, Inc
City/State/Country
Santa Clara, CA, US
Establishment Address
5490 Great America Pkwy, Santa Clara, CA 95054, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Auris Health, Inc. (Owner Number: 10057462)
Owner / Operator Contact Address
5490 Great America Parkway, Santa Clara, CA 95054, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Stone Retrieval Basket Monarch Platform, Urology Monarch Platform MON-000006-RFB, MONARCH™ Platform, Refurbished Guided Percutaneous Access Needle Monarch Bronchoscope MONARCH Bronchoscope Reprocessed Monarch Platform (MON-000006) Monarch Bronchoscope Monarch Platform Drape Kit, CFG Drape, and Sheath Mount Drape

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FFL Dislodger, Stone, Basket, Ureteral, Metal Gastroenterology, Urology Class 2 876.4680 2022-12-28
LJH System, Irrigation, Urological Gastroenterology, Urology Class 2 876.5130 2022-05-25
GCB Needle, Catheter General, Plastic Surgery Class 1 878.4200 2022-05-25
FGA Kit, Nephroscope Gastroenterology, Urology Class 2 876.1500 2022-05-25
LJE Catheter, Nephrostomy Unknown Class U N/A 2022-05-25
FGB Ureteroscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2022-05-25
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2021-07-13
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2021-07-13
GCB Needle, Catheter General, Plastic Surgery Class 1 878.4200 2022-12-28
QNW Reprocessed Bronchoscope Ear, Nose, Throat Class 2 874.4680 2024-01-10
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2018-04-09
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2018-04-09
QNW Reprocessed Bronchoscope Ear, Nose, Throat Class 2 874.4680 2021-03-15
PUI Drape, Surgical, Exempt General, Plastic Surgery Class 2 878.4370 2022-12-28

Official Correspondent

Joy Sacmar

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Auris Health, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3023460764 Auris Health, Inc. San Jose, CA, US

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
K243523 Siemens Medical Solutions USA, Inc. NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime 2025-02-12

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
Z-0007-2011 GE Medical Systems, LLC 2
HiSpeed X/i Computed Tomography operator consoles with the Model Number 2153675 and 2247802. The expected usage of this product is to generate head and whole body CT images of human subjects.
Z-0009-2017 Philips Medical Systems 2
Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0010-2017 Philips Medical Systems 2
Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0011-2017 Philips Medical Systems 2
Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017425975. Last updated year: 2026. Please use registration number 3017425975 when referencing this establishment in official correspondence.
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