Banyan Medical, LLC

Warwick, RI, US

Banyan Medical, LLC appears in FDA device records in Warwick, RI. FDA records list one 510(k) clearance, no PMA records and no registered establishments. As of 2026-09-10, FDA records show 2 recalls for this company.

510(k) clearances: 1
PMA records: 0
Recall records: 2
Registered establishments: 0

510(k) clearance history

FDA records hold 1 510(k) clearance for Banyan Medical, LLC in 2014.

Clearances by year, as a table

510(k) clearance decisions for Banyan Medical, LLC, by decision year
Year	Clearances
2014	1

510(k) clearances on record, most recent first
K number	Device	Product code	Decision	Decision date
K133375	BANYAN MEDICAL DISPOSABLE SECONDARY CANNULA AND TROCAR	GCJ	Substantially Equivalent	2014-01-17

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

GCJLaparoscope, General & Plastic Surgery

Recall records

Device recall records naming this company, most recent first
Recall	Product	Reason	Classification	Initiated	Status
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	Potential lack of assurance of sterility	Class II	2016-09-07	Terminated
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	Potential lack of assurance of sterility	Class II	2016-09-07	Terminated

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Data as of 2026-09-28, FDA export datePage updated 2026-09-05Source: openFDA, public domain