FDA Registration
Active
🇺🇸 United States
STRATOS Endoscopic Carpal Tunnel Release System
Reg #: 2437731
·
FEI: 3001617730
·
Expires 2025
Products
1
Proprietary Names
20
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- A.M. SURGICAL, INC.
- Registration Number
- 2437731
- FEI Number
- 3001617730
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 285 MIDDLE COUNTRY RD SUITE 206
- City
- SMITHTOWN
- State
- NY
- ZIP
- 11787
- Country
- US
Owner / Operator
- Firm Name
- A.M. SURGICAL, INC.
- Operator Number
- 9032254
- Address
- 402 Amherst Street Ste 300, --
- City
- Nashua
- State
- NH
- Postal Code
- 03063
- Country
- US
- Correspondent
- Vincent F Pascale
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2010-10-21 |
Proprietary Names
STRATOS Endoscopic Carpal Tunnel Release System
Endoscopic Trigger Finger Release (ETFR)
Endoscopic Trigger Shield Release
STRATOS Endoscopic Plantar Fascia Release System
STRATOS Endoscopic Gastrocnemius Release System
Ultra Endoscopic Plantar Fascia Release System
EndoSleeve
Ultra Endoscopic Soft Tissue Release System
Endoscopic Cubital Tunnel Release (ECUTR)
LITE Endoscopic Plantar Fascia Release System
LITE Endoscopic Release System
LITE Endoscopic Gastrocnemius Release System
LITE Endoscopic Tarsal Tunnel Release System
Ultra Endoscopic Gastrocnemius Release System
LITE Endoscopic Mortons Neuroma Decompression System
RETRA Endoscopic Carpal Tunnel Release System
RETRA Endoscopic Cubital Tunnel Release System
STRATOS RETRA Endoscopic Gastrocnemius Release System
STRATOS RETRA Endoscopic Plantar Fascia Release System
STRATOS RETRA Endoscopic Carpal Tunnel Release System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility