Data / Medical devices / United States / Trice Medical

Trice Medical: FDA-registered device maker in Malvern, PA, United States, 6 510(k) clearances

Name: Trice Medical FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Trice Medical is registered with the FDA (registration 3010760216) in Malvern, PA, United States. It lists 10 device types. The FDA files 6 510(k) clearances under its listings, the newest dated November 18, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3010760216
Address: 40 General Warren Blvd Suite 100, Malvern, PA, United States, 19355
Owner or operator: Trice Medical (10046410)
Roles: Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
First device listed: March 19, 2014
Registered through: 2026
Brand names listed: Advansor Trigger Finger Release System, C-MOR Visualization Device, SegWAY Guides, SegWAY Instrument Case, SegWAY Instruments, SegWay Disposable ECTR Kit, Tenex 2nd Generation Console, Tenex 2nd Generation MicroTip and more

Devices it lists

Device	Product code	Class	Role	Source
Arthroscope	HRX	2	Complaint file establishment, Manufacturer, Specification developer	accessdata.fda.gov
Guide, Surgical, Instrument	FZX	1	Complaint file establishment, Specification developer	accessdata.fda.gov
Instrument, Ultrasonic Surgical	LFL	U	Complaint file establishment, Manufacturer	accessdata.fda.gov
Kit, Surgical Instrument, Disposable	KDD	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Orthopedic Manual Surgical Instrument	LXH	1	Complaint file establishment, Manufacturer	accessdata.fda.gov
Probe	HXB	1	Complaint file establishment, Specification developer	accessdata.fda.gov
System, Imaging, Pulsed Doppler, Ultrasonic	IYN	2	Complaint file establishment, Manufacturer, Repackager or relabeler	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Complaint file establishment, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Complaint file establishment, Manufacturer, Repackager or relabeler	accessdata.fda.gov
Tray, Surgical, Instrument	FSM	1	Complaint file establishment, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
November 18, 2024	K241700	Tenex 2nd Generation System	LFL	Substantially Equivalent	Trice Medical, Inc.	accessdata.fda.gov
September 15, 2021	K212556	mi-eye 3 needlescope with cannula, mi-tablet 3	HRX	Substantially Equivalent	Trice Medical, Inc.	accessdata.fda.gov
April 13, 2017	K163443	Interson USB Ultrasound System	IYN	Substantially Equivalent	Interson Corporation	accessdata.fda.gov
September 16, 2016	K162475	mi-eye 2, mi-eye 2 monitor	HRX	Substantially Equivalent	Trice Medical	accessdata.fda.gov
July 29, 2014	K141119	CAMERA ENABLED PROBE	HRX	Substantially Equivalent	Trice Medical, Inc.	accessdata.fda.gov
March 2, 2010	K093717	C-MOR VISUALIZATION DEVICE	HRX	Substantially Equivalent	Axis Surgical Technologies, Inc.	accessdata.fda.gov

Compare with other makers

Updated November 18, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.