FDA Registration
Active
🇺🇸 United States
Focused Irrigating Bipolar Forceps
Reg #: 3007589150
·
FEI: 3007589150
·
Expires 2025
Products
1
Proprietary Names
5
Establishment Types
5
Classifications
1
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
- K123172
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 |
|---|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2013-05-17 |
Proprietary Names
Focused Irrigating Bipolar Forceps
Irrigating Bipolar Forceps
Focused Bipolar Forceps
Strandard Bipolar Forceps
Illuminated Bipolar Forceps
Establishment Types
Remanufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device