BANYAN MEDICAL DISPOSABLE SECONDARY CANNULA AND TROCAR— 510(k) K133375
Substantially EquivalentBanyan Medical, LLC
FDA 510(k) clearance K133375 for BANYAN MEDICAL DISPOSABLE SECONDARY CANNULA AND TROCAR, Substantially Equivalent on 2014-01-17. Applicant: Banyan Medical, LLC. Device class: 2.
Clearance details
- Applicant
- Banyan Medical, LLC
- Product code
- Product code GCJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Warwick, RI, US
Recent devices under product code GCJ
view allAdverse events under product code GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K133375
K-number listed on FDA's recall record- Z-0074-2017 — Banyan Medical 5 x 55mm Regular Pyramidal Trocar and 2x Cannula. For Laproscopic Use- Sterile Single Use Only. Product Code 400-008
- Z-0075-2017 — Banyan Medical 5 x 55mm Pyramidal Tip Trocar w/ 2X Cannula w/ Sideport. Laproscopic Use- Sterile Single Use Only Product Code 400-009
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133375.
Data sourced from openFDA. This site is unofficial and independent of the FDA.