SRI Surgical
FDA Regulatory Profile
SRI Surgical appears in FDA public data with 1 recall, 1 510(k) clearance, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2300-2012, Class II) was initiated on July 16, 2008. Its most recent 510(k) clearance was granted on May 29, 2009.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 1
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2300-2012 | Class II | Various SRI Surgical Disposable Accessory Packs. SRI's Disposable Accessory Packs (also commonly | July 16, 2008 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K090383 | SRI LEVEL II SURGICAL GOWN | May 29, 2009 |