The following data is part of a De Novo classification by Plexus Biomedical Inc. with the FDA for Hem-avert Perianal Stabilizer.
| DeNovo ID | DEN090011 |
| Device Name: | HEM-AVERT PERIANAL STABILIZER |
| Classification | Hemorrhoid Prevention Pressure Wedge |
| Applicant | PLEXUS BIOMEDICAL INC. 70 Clay Street suite 2 Oakland, TN 38060 |
| Contact | David Blurton |
| Product Code | OOA |
| CFR Regulation Number | 884.5200 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K083692 |
| Review Advisory Board | Obstetrics/Gynecology |
| Classification Advisory | Obstetrics/Gynecology |
| Type | Post-NSE |
| Date Received | 2009-08-18 |
| Decision Date | 2011-01-13 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |