The following data is part of a De Novo classification by Ethicon Endo-surgery with the FDA for Percutaneous Surgical Set With 5mm Or 10mm Attachments.
| DeNovo ID | DEN110016 |
| Device Name: | PERCUTANEOUS SURGICAL SET WITH 5MM OR 10MM ATTACHMENTS |
| Classification | Percutaneous Surgical Set With Attachments |
| Applicant | ETHICON ENDO-SURGERY 4545 Creek Rd. Cincinnati, OH 45242 |
| Contact | Thomas Bosticco |
| Product Code | OXT |
| CFR Regulation Number | 878.4805 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | K110431 |
| Review Advisory Board | General & Plastic Surgery |
| Classification Advisory | General & Plastic Surgery |
| Type | Post-NSE |
| Date Received | 2011-09-21 |
| Decision Date | 2012-04-30 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |