Data / Medical devices / United States / Stetrix Inc.
Stetrix Inc.: FDA-registered device maker in Memphis, TN, United States, 1 510(k) clearance
Stetrix Inc. is registered with the FDA (registration 3005550381) in Memphis, TN, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 19, 2016. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3005550381
- Address
- 6935 Appling Farms Pkwy Ste 103, Memphis, TN, United States, 38133
- Owner or operator
- Stetrix Inc. (9078700)
- Roles
- Manufacturer
- First device listed
- October 18, 2005
- Registered through
- 2027
- Brand names listed
- Hem-Avert, Labor Guard, Tissue Retention System (TRS), Pannus Retention System (PRS), Panni, Panni-XL, Jannus
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Pressure Applying | KNM | 1 | Manufacturer | accessdata.fda.gov |
| Hemorrhoid Prevention Pressure Wedge | OOA | 2 | Manufacturer | accessdata.fda.gov |
| Pressure Wedge, Perianal, For Reduction Of Cesarean Delivery | PNU | 2 | Manufacturer | accessdata.fda.gov |
| Tape, Orthopedic | HXT | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| December 19, 2016 | DEN160005 | Hem-Avert Perianal Stabilizer | PNU | Unknown | Stetrix, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Device, Pressure Applying
- All makers of Tape, Orthopedic
- All makers of Hemorrhoid Prevention Pressure Wedge
Updated December 19, 2016. 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.