Data / Medical devices / United States / Titus Medical LLC
Titus Medical LLC: FDA-registered device maker in Rock Hill, SC, United States, 2 510(k) clearances
Titus Medical LLC is registered with the FDA (registration 3008367216) in Rock Hill, SC, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 30, 2010. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3008367216
- Address
- 116 E. Main Street, Rock Hill, SC, United States, 29730
- Owner or operator
- Titus Medical LLC (10032256)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- June 1, 2010
- Registered through
- 2026
- Brand names listed
- ENDO SAMPLER, H/S Catheter Set, HSG Catheter, SonoCath, UTERINE SOUNDS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cannula, Manipulator/Injector, Uterine | LKF | 2 | Manufacturer | accessdata.fda.gov |
| Curette, Suction, Endometrial (And Accessories) | HHK | 2 | Manufacturer | accessdata.fda.gov |
| Sound, Uterine | HHM | 1 | Manufacturer | accessdata.fda.gov |
| Tubing, Pressure And Accessories | BYX | 1 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| April 30, 2010 | K092969 | H/S CATHETER SET 5 FRENCH, MODEL 61-5005F, H/S CATHETER SET 7 FRENCH, MODEL 61-5007F | LKF | Substantially Equivalent | Sterling Medical, Inc. | accessdata.fda.gov |
| April 20, 1999 | K990387 | ENDOMETRIAL SAMPLER | HHK | Substantially Equivalent | U.A. Medical Products, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Cannula, Manipulator/Injector, Uterine
- All makers of Tubing, Pressure And Accessories
- All makers of Sound, Uterine
- All makers of Curette, Suction, Endometrial (And Accessories)
Updated April 30, 2010. 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.