FDA Registration
Active
🇺🇸 United States
SURETEK MEDICAL
Reg #: 3005575604
·
FEI: 3005575604
·
Expires 2026
Products
14
Proprietary Names
21
Establishment Types
1
Classifications
14
Registration Details
- Registration Name
- SURETEK MEDICAL
- Registration Number
- 3005575604
- FEI Number
- 3005575604
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 25-B MAPLE CREEK CIRCLE
- City
- GREENVILLE
- State
- SC
- ZIP
- 29607
- Country
- US
Regulatory Submissions
- 510(k) Number
- K052690
Owner / Operator
- Firm Name
- SURETEK MEDICAL
- Operator Number
- 9082027
- Address
- 25-B MAPLE CREEK CIRCLE, --
- City
- Greenville
- State
- SC
- Postal Code
- 29607
- Country
- US
- Correspondent
- MIKE - SAMMON, PH.D.
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2006-01-20 |
| Burr, Orthopedic | HTT | Class 1 | Orthopedic | No | 2006-01-20 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2012-11-23 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2006-01-20 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2006-01-20 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2006-01-20 |
| Cannula, Sinus | KAM | Class 1 | General, Plastic Surgery | No | 2013-12-15 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2006-02-16 |
| Passer | HWQ | Class 1 | Orthopedic | No | 2013-12-15 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2006-02-16 |
| Bur, Ear, Nose And Throat | EQJ | Class 1 | Ear, Nose, Throat | No | 2008-04-20 |
| Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed | NUJ | Class 2 | General, Plastic Surgery | No | 2006-06-16 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2006-01-20 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2006-01-20 |
Proprietary Names
Reprocessed Orthopedic Saw Blades
Reprocessed Surgical Bur
Reprocessed Manual ENT Instrument
Reprocessed Inflation Syringe
Reprocessed Sinus Cannula
Reprocessed Sinuplasty Balloon Catheter
Reprocessed Orthopedic Bone Tap
Reprocessed Surgical Reamer
Reprocessed Suture Grasper, Lasso, Retriever
Reprocessed ENT Shavers
Reprocessed Arthroscopic Shavers and Burs
Reprocessed Passer
Reprocessed Orthopedic Burs and Saw Blades
Reprocessed ENT Blades and Burs
SURETEK REPROCESSED ELE
Reprocessed Monopolar and Bipolar Electrosurgical Cutting and Coagulation Devices
Reprocessed Surgical Rasp
Reprocessed Surgical Drill Bit
Reprocessed Monopolar Scissors and Dissectors
Reprocessed Monopolar and Bipolar Arthroscopic Cutting and Coagulation Instruments
Reprocessed Bipolar Graspers and Cutting Instruments
Establishment Types
Reprocess Single-Use Device