Auris Health, Inc.

FDA Device Registration & Listing · San Jose, CA, US · Registration 3023460764

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
3023460764
FEI Number
3023460764
Entity Name
Auris Health, Inc.
City/State/Country
San Jose, CA, US
Establishment Address
170 Baytech Drive, San Jose, CA 95134, US
Establishment Type(s)
Repack or Relabel Medical Device,Manufacture Medical Device
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
K243219
PMA Number
N/A

All Registered Proprietary Names

Guided Percutaneous Access Needle Monarch Platform Drape Kit, CFG Drape, and Sheath Mount Drape Monarch Bronchoscope Monarch Bronchoscope MONARCH Bronchoscope Reprocessed Monarch Navigation Field Generator Mount (MON-000006 - 210-000343-00) Monarch Tower (MON-000006 - 210-001896-00) Monarch Cart (MON-000006 - 210-001887-00) Bronchoscope Sheath Valve (MBR-000020) Bronchoscope Patient Introducer Kit (MBR-000017) Monarch Controller (MON-000706) Monarch Navigation Field Generator (MON-000006 - 210-000344-00) Monarch Navigation Patient Sensors (MON-000705) Monarch Pre-op Planning System Kit (MON-000707) Monarch Advanced Imaging Accessory Kit (MON-000709) Bronchoscope Fluidics Tubing (MBR-000218) Bronchoscope Patient Introducer Mount (MON-000006 - 210-000346-00) Navigation Patient Patches (MBR-000016) Monarch Bronchoscope (MBR-000211-A) Cytology Brush (MBR-000015) Biopsy Forceps - Smooth Cup (MBR-000014) Monarch Pre-Op Planning System Kit (MON-000708) Monarch Platform, Urology Monarch Platform (MON-000006) Bronchoscope Patient Introducer Mount (210-000346-00) MON-000008-RFB, MONARCH™ Platform, Refurbished Bronchoscope (flexible or rigid) - Biopsy Forceps - Smooth Cup (MBR-000014); Bronchoscope (flexible or rigid) - Monarch Platform (MON-000008) Monarch Controller (MON-000712) Monarch Advanced Imaging Accessory Kit (MON-000709); Monarch Navigation Patient Sensors (MON-000705) Bronchoscope Patient Introducer Kit (MBR-000017) Monarch Navigation Field Generator (210-000344-00) Bronchoscope Fluidics Tubing (MBR-000218) Monarch Bronchoscope (MBR-000211-A) MONARCH Extended Patient Introducer Mount, MON-000713 Monarch Navigation Patient Patches (MBR-000016) System, x-ray, tomography, computed - Monarch Platform (MON-000008) Cytology Brush (MBR-000015) Monarch Navigation Field Generator Mount (210-000343-00) Monarch Tower (MON-000008) 210-007591-00 Bronchoscope Sheath Valve (MBR-000020) Monarch Cart (MON-000008 - 210-007592) MON-000710 Monarch Pre-Op Planning System Kit

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GCB Needle, Catheter General, Plastic Surgery Class 1 878.4200 2022-12-28
PUI Drape, Surgical, Exempt General, Plastic Surgery Class 2 878.4370 2022-12-28
QNW Reprocessed Bronchoscope Ear, Nose, Throat Class 2 874.4680 2021-03-15
QNW Reprocessed Bronchoscope Ear, Nose, Throat Class 2 874.4680 2024-01-10
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2020-07-14
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2020-07-14
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
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 2025-02-25
EOQ Bronchoscope (Flexible Or Rigid) Ear, Nose, Throat Class 2 874.4680 2025-02-25
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2025-02-25

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
3017425975 Auris Health, Inc Santa Clara, CA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
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
K781431 General Electric Co. ELECTRIC CT/T OPERATOR DISPLAY CONSOLE 1978-09-07

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
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.

Similar Registrations

Registration Number Establishment Name Location
2134812 VASCULAR SOLUTIONS LLC Maple Grove, MN, US
2246552 Isomedix Operations Inc. S Plainfield, NJ, US
1625425 ARGON MEDICAL DEVICES INC. ATHENS, TX, US
3010041511 Teleflex LLC (NADC) Olive Branch, MS, US
1820334 Cook Incorporated Bloomington, IN, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023460764. Last updated year: 2026. Please use registration number 3023460764 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.