Endoplus, Inc.
FDA Regulatory Profile
Endoplus, Inc. appears in FDA public data with 2 recalls, 1 510(k) clearance, 6 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2265-2013, Class II) was initiated on July 15, 2013. Its most recent 510(k) clearance was granted on December 23, 2015.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 1
- Inspections
- 6
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2265-2013 | Class II | ENDOPLUS; Precision Laparoscopic Instruments; REF 345VA; Description 5 mm Traumatic Grasper S/A, S | July 15, 2013 |
| Z-2264-2013 | Class II | ENDOPLUS; Precision Laparoscopic Instruments; REF 346VA; Description 5mm Atraumatic Grasper S/A, S | July 15, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K151567 | ENDOPLUS hand-held laparoscopic instruments | December 23, 2015 |