FDA Registration
Active
🇺🇸 United States
U.S. SURGITECH, INC.
Reg #: 3004777218
·
FEI: 3004777218
·
Expires 2026
Products
12
Proprietary Names
2
Establishment Types
2
Classifications
12
Registration Details
- Registration Name
- U.S. SURGITECH, INC.
- Registration Number
- 3004777218
- FEI Number
- 3004777218
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 551 Kimberly Drive
- City
- Carol Stream
- State
- IL
- ZIP
- 60188
- Country
- US
Regulatory Submissions
- 510(k) Number
- K911316
Owner / Operator
- Firm Name
- U.S. SURGITECH, INC.
- Operator Number
- 9067640
- Address
- 551 Kimberly Drive
- City
- Carol Stream
- State
- IL
- Postal Code
- 60188
- Country
- US
- Correspondent
- MAAZ - MEAH
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 2018-02-03 |
| Device, Transfer, Patient, Manual | FMR | Class 1 | General Hospital | No | 2025-12-24 |
| Tube, Aspirating, Flexible, Connecting | BYY | Class 2 | General Hospital | No | 2026-06-16 |
| Forceps, Biopsy, Non-Electric | FCL | Class 1 | Gastroenterology, Urology | No | 2024-09-02 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2019-02-01 |
| Pad, Heating, Powered | IRT | Class 2 | Physical Medicine | No | 2025-12-24 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2024-08-29 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2026-06-16 |
| Gauze/Sponge, Internal, X-Ray Detectable | GDY | Class 1 | General, Plastic Surgery | No | 2023-01-23 |
| Needle, Aspiration And Injection, Disposable | GAA | Class 1 | General, Plastic Surgery | No | 2018-02-03 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-07-22 |
| Adaptor, Bulbs, Miscellaneous, For Endoscope | FFY | Class 1 | Gastroenterology, Urology | No | 2025-01-07 |
Proprietary Names
SurgyCut Grasping Forceps
SurgyCut Biopsy Forceps
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device