Data / Medical devices / United States / Suretek Medical
Suretek Medical: FDA-registered device maker in Greenville, SC, United States, 2 510(k) clearances
Suretek Medical is registered with the FDA (registration 3005575604) in Greenville, SC, United States. It lists 14 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 12, 2006. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005575604
- Address
- 25-B Maple Creek Circle, Greenville, SC, United States, 29607
- Owner or operator
- SURETEK MEDICAL (9082027)
- Roles
- Reprocessor
- First device listed
- January 20, 2006
- Registered through
- 2026
- Brand names listed
- Reprocessed Arthroscopic Shavers and Burs, Reprocessed Bipolar Graspers and Cutting Instruments, Reprocessed ENT Blades and Burs, Reprocessed ENT Shavers, Reprocessed Inflation Syringe, Reprocessed Manual ENT Instrument, Reprocessed Monopolar Scissors and Dissectors, Reprocessed Monopolar and Bipolar Arthroscopic Cutting and Coagulation Instruments and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Arthroscopic | NBH | 1 | Reprocessor | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Reprocessor | accessdata.fda.gov |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | 1 | Reprocessor | accessdata.fda.gov |
| Bur, Ear, Nose And Throat | EQJ | 1 | Reprocessor | accessdata.fda.gov |
| Burr, Orthopedic | HTT | 1 | Reprocessor | accessdata.fda.gov |
| Cannula, Sinus | KAM | 1 | Reprocessor | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed | NUJ | 2 | Reprocessor | accessdata.fda.gov |
| Instrument, Cutting, Orthopedic | HTZ | 1 | Reprocessor | accessdata.fda.gov |
| Instrument, Ent Manual Surgical | LRC | 1 | Reprocessor | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Reprocessor | accessdata.fda.gov |
| Passer | HWQ | 1 | Reprocessor | accessdata.fda.gov |
| Rasp | HTR | 1 | Reprocessor | accessdata.fda.gov |
| Reamer | HTO | 1 | Reprocessor | accessdata.fda.gov |
| Tap, Bone | HWX | 1 | Reprocessor | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 12, 2006 | K052690 | SURETEK REPROCESSED LAPAROSCOPIC INSTRUMENTS | NUJ | Substantially Equivalent | Suretek Medical | accessdata.fda.gov |
| May 10, 2006 | K052692 | SURETEK MEDICAL REPROCESSED ELECTROSURGICAL ELECTRODES | NUJ | Substantially Equivalent | Suretek Medical | accessdata.fda.gov |
Compare with other makers
- All makers of Passer
- All makers of Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed
- All makers of Blade, Saw, General & Plastic Surgery, Surgical
- All makers of Burr, Orthopedic
- All makers of Instrument, Ent Manual Surgical
- All makers of Cannula, Sinus
Updated May 12, 2006. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.