FDA Registration
Active
🇺🇸 United States
Subcyclo
Reg #: 3007589150
·
FEI: 3007589150
·
Expires 2025
Products
3
Proprietary Names
2
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- KATALYST SURGICAL, LLC
- Registration Number
- 3007589150
- FEI Number
- 3007589150
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 754 Goddard ave
- City
- Chesterfield
- State
- MO
- ZIP
- 63005
- Country
- US
Regulatory Submissions
- 510(k) Number
- K163632
Owner / Operator
- Firm Name
- Katalyst Surgical, LLC
- Operator Number
- 10029103
- Address
- 754 Goddard Avenue
- City
- Chesterfield
- State
- MO
- Postal Code
- 63005
- Country
- US
- Correspondent
- Meryl Koch
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Endoilluminator | MPA | Class 2 | Gastroenterology, Urology | No | 2017-07-19 |
| Lens, Surgical, Laser, Accesssory, Ophthalmic Laser | LQJ | Class 2 | Ophthalmic | No | 2017-07-19 |
| Image, Illumination, Fiberoptic, For Endoscope | FFS | Class 2 | Gastroenterology, Urology | No | 2017-07-19 |
Proprietary Names
Subcyclo
Ciliprobe Transsceral Cyclophotocoagulation Probe
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device