FDA Product Code
FDA Product Code SIR — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- General, Plastic Surgery
- 21 CFR Citation
- 878.4966
510(k) Clearances — 1 record
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| DEN250068 | OTTAVA Robotic Surgical System | Auris Health, Inc., part of Johnson & Johnson MedTech | 2026-07-21 | Direct | — |
Product code SIR · Class II · General, Plastic Surgery. Data: openFDA.