FDA Registration
Active
🇺🇸 United States
TOOLS FOR SURGERY, LLC
Reg #: 3004550973
·
FEI: 3004550973
·
Expires 2026
Products
7
Proprietary Names
14
Establishment Types
3
Classifications
7
Registration Details
- Registration Name
- TOOLS FOR SURGERY, LLC
- Registration Number
- 3004550973
- FEI Number
- 3004550973
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1339 Stony Brook Rd
- City
- Stony Brook
- State
- NY
- ZIP
- 11790
- Country
- US
Regulatory Submissions
- 510(k) Number
- K242901
Owner / Operator
- Firm Name
- Tools For Surgery, LLC
- Operator Number
- 9060703
- Address
- 8 Technology Drive, #100
- City
- East Setauket
- State
- NY
- Postal Code
- 11733
- Country
- US
- Correspondent
- Arnold R Leiboff
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2025-11-19 |
| Rod, Colostomy | EZP | Class 2 | Gastroenterology, Urology | No | 2018-03-03 |
| Surgical Instruments, G-U, Manual (And Accessories) | KOA | Class 1 | Gastroenterology, Urology | No | 2005-12-28 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2020-04-21 |
| Catheter, Irrigation | GBX | Class 1 | General, Plastic Surgery | No | 2016-10-28 |
| Dilator, Rectal | FFP | Class 1 | Gastroenterology, Urology | No | 2005-12-28 |
| Staple, Implantable | GDW | Class 2 | General, Plastic Surgery | No | 2007-12-31 |
Proprietary Names
ZZIREN® Orogastric Tube
BARBELL LOOP OSTOMY DEVICE
CIRCULAR STAPLER ANVIL SIZER SET
CIRCULAR STAPLER HEAD SIZER SET
SIREN SGT
COLORECTAL AIR SYRINGE-OP
COLORECTAL AIR SYRINGE-LP
BARIATRIC AIR SYRINGE
WIKI DRAIN
WIKI DRAINS
SOHN'S DILATORS
YOUNG'S STYLE RECTAL DILATORS
HEMORRHAGE OCCLUDER PIN
HEMORRHAGE OCCLUDER PIN WITH APPLICATOR
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device