Peters Surgical
FDA Regulatory Profile
Peters Surgical appears in FDA public data with 2 recalls, 7 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2676-2014, Class II) was initiated on June 25, 2014. Its most recent 510(k) clearance was granted on October 11, 2024.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 7
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2676-2014 | Class II | The synthetic non-absorbable surgical sutures CARDIOFLON Evolution are composed of polyester [poly(e | June 25, 2014 |
| Z-2675-2014 | Class II | The synthetic non-absorbable surgical sutures CARDIOXYL are composed of a polyester [poly(ethylene t | June 25, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K233265 | Monotime and Optime R | October 11, 2024 |
| K232372 | Peters Surgical ADVANTIME Absorbable Suture (ADVANTIME) | July 12, 2024 |
| K071281 | UNIRING - ANNULOPLASTY RING WITH SIZERS | August 3, 2007 |
| K060465 | PREMIO | January 17, 2007 |
| K060163 | CARDIOFLON, CARDIOXYL | October 11, 2006 |
| K062366 | OPTIME, SINUSORB PGA | October 2, 2006 |
| K052701 | COROLENE | December 13, 2005 |