FDA Registration
Active
🇺🇸 United States
Auris Health, Inc.
Reg #: 3023460764
·
FEI: 3023460764
·
Expires 2026
Products
10
Proprietary Names
40
Establishment Types
2
Classifications
10
Registration Details
- Registration Name
- Auris Health, Inc.
- Registration Number
- 3023460764
- FEI Number
- 3023460764
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 170 Baytech Drive
- City
- San Jose
- State
- CA
- ZIP
- 95134
- Country
- US
Regulatory Submissions
- 510(k) Number
- K203614
Owner / Operator
- Firm Name
- Auris Health, Inc.
- Operator Number
- 10057462
- Address
- 5490 Great America Parkway
- City
- Santa Clara
- State
- CA
- Postal Code
- 95054
- Country
- US
- Correspondent
- Joy Sacmar
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Needle, Catheter | GCB | Class 1 | General, Plastic Surgery | No | 2022-12-28 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2022-12-28 |
| Reprocessed Bronchoscope | QNW | Class 2 | Ear, Nose, Throat | No | 2021-03-15 |
| Bronchoscope (Flexible Or Rigid) | EOQ | Class 2 | Ear, Nose, Throat | No | 2020-07-14 |
| System, X-Ray, Tomography, Computed | JAK | Class 2 | Radiology | No | 2020-07-14 |
| System, Irrigation, Urological | LJH | Class 2 | Gastroenterology, Urology | No | 2022-05-25 |
| Kit, Nephroscope | FGA | Class 2 | Gastroenterology, Urology | No | 2022-05-25 |
| Catheter, Nephrostomy | LJE | Class U | Unknown | No | 2022-05-25 |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | Class 2 | Gastroenterology, Urology | No | 2022-05-25 |
| Dislodger, Stone, Basket, Ureteral, Metal | FFL | Class 2 | Gastroenterology, Urology | No | 2022-12-28 |
Proprietary Names
Guided Percutaneous Access Needle
Monarch Platform Drape Kit, CFG Drape, and Sheath Mount Drape
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 Field Generator (210-000344-00)
MONARCH Extended Patient Introducer Mount, MON-000713
Monarch Navigation Patient Patches (MBR-000016)
System, x-ray, tomography, computed - Monarch Platform (MON-000008)
Monarch Navigation Field Generator Mount (210-000343-00)
Monarch Tower (MON-000008) 210-007591-00
Monarch Cart (MON-000008 - 210-007592)
MON-000710 Monarch Pre-Op Planning System Kit
Stone Retrieval Basket
Monarch Platform
MON-000006-RFB, MONARCH Platform, Refurbished
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device