The following data is part of a premarket notification filed by Banyan Medical, Llc. with the FDA for Banyan Medical Disposable Secondary Cannula And Trocar.
| Device ID | K133375 |
| 510k Number | K133375 |
| Device Name: | BANYAN MEDICAL DISPOSABLE SECONDARY CANNULA AND TROCAR |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | BANYAN MEDICAL, LLC. 89 BELLOWS STREET Warwick, RI 02888 |
| Contact | Tammy Healey |
| Correspondent | Tammy Healey BANYAN MEDICAL, LLC. 89 BELLOWS STREET Warwick, RI 02888 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-04 |
| Decision Date | 2014-01-17 |
| Summary: | summary |