Banyan Medical, LLC
FDA Regulatory Profile
Banyan Medical, LLC appears in FDA public data with 2 recalls, 1 510(k) clearance, 3 FDA inspections, and 1 compliance action on record. Its most recent recall (Z-0075-2017, Class II) was initiated on September 7, 2016. Its most recent 510(k) clearance was granted on January 17, 2014.
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 1
- Inspections
- 3
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0075-2017 | Class II | Banyan Medical 5 x 55mm Pyramidal Tip Trocar w/ 2X Cannula w/ Sideport. Laproscopic Use- Sterile Si | September 7, 2016 |
| Z-0074-2017 | Class II | Banyan Medical 5 x 55mm Regular Pyramidal Trocar and 2x Cannula. For Laproscopic Use- Sterile Singl | September 7, 2016 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K133375 | BANYAN MEDICAL DISPOSABLE SECONDARY CANNULA AND TROCAR | January 17, 2014 |