FDA Registration
Active
🇺🇸 United States
Vortex Surgical
Reg #: 3013002167
·
FEI: 3013002167
·
Expires 2026
Products
13
Proprietary Names
8
Establishment Types
5
Classifications
13
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Registration Details
- Registration Name
- Vortex Surgical
- Registration Number
- 3013002167
- FEI Number
- 3013002167
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4 Research Park Dr, Suite 124
- City
- Saint Charles
- State
- MO
- ZIP
- 63304
- Country
- US
Regulatory Submissions
- 510(k) Number
- K191846
Owner / Operator
- Firm Name
- Vortex Surgical
- Operator Number
- 10052162
- Address
- 4 Research Park Dr, Suite 124
- City
- Saint Charles
- State
- MO
- Postal Code
- 63304
- Country
- US
- Correspondent
- Andrew C Ritts
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Marker, Sclera | HMQ | Class 1 | Ophthalmic | No | 2024-07-25 |
| Photocoagulator And Accessories | HQB | Class 2 | Ophthalmic | No | 2020-01-22 |
| Forceps, Ophthalmic | HNR | Class 1 | Ophthalmic | No | 2018-03-09 |
| Hook, Ophthalmic | HNQ | Class 1 | Ophthalmic | No | 2016-11-28 |
| Depressor, Orbital | HNX | Class 1 | Ophthalmic | No | 2019-08-23 |
| Cannula, Ophthalmic | HMX | Class 1 | Ophthalmic | No | 2016-11-28 |
| Lens, Contact, Polymethylmethacrylate, Diagnostic | HJK | Class 2 | Ophthalmic | No | 2024-04-09 |
| Led Light Source | NTN | Class 2 | Gastroenterology, Urology | No | 2024-04-09 |
| Light Source, Fiberoptic, Routine | FCW | Class 2 | Gastroenterology, Urology | No | 2024-04-09 |
| Transilluminator, Ac-Powered | HJM | Class 2 | Ophthalmic | No | 2023-01-17 |
| Cannula, Ophthalmic, Posterior Capsular Polishing, Polyvinyl Acetal | MXY | Class 1 | Ophthalmic | No | 2016-11-28 |
| Kit, Surgical Instrument, Disposable | KDD | Class 1 | General, Plastic Surgery | No | 2016-11-30 |
| Endoilluminator | MPA | Class 2 | Gastroenterology, Urology | No | 2022-12-29 |
Proprietary Names
ACTU8 Forceps
Todorich Illuminated Depressor (TID)
Soft Tip Cannula
JOD 27GA CANN W/ SILICONE TUBING TIP
Beacon Illuminated Depressor
TID Pharos Illuminated Depressor
Injection Kits
MAXReach Laser Probe
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198