Question 1

What types of medical devices does Veran Medical Technologies Inc. primarily manufacture?

Accepted Answer

Veran Medical Technologies Inc. specializes in endoscopic control and video-imaging systems. Their portfolio includes video processors, navigation systems, and steerable catheters with real-time tip tracking. The most common category is endoscopic control/video-imaging systems, such as the SPiN Vision Video Bronchoscope System and the IG4 Image-Guided System, which are designed for precise procedural guidance in thoracic and endobronchial applications.

Question 2

Where is Veran Medical Technologies Inc. based, and where are their devices intended for use?

Accepted Answer

Veran Medical Technologies Inc. is based in the United States. Their devices are developed and marketed with a focus on the U.S. market, where they are intended for clinical use.

Question 3

Which regulatory registries list Veran Medical Technologies Inc.’s devices?

Accepted Answer

Veran Medical Technologies Inc.’s devices are listed in the FDA’s 510(k) and UDI (Unique Device Identification) databases. These registries track medical devices that have undergone the necessary regulatory pathways, such as the 510(k) premarket notification process, to demonstrate substantial equivalence to legally marketed devices.

Question 4

How are Veran Medical Technologies Inc.’s devices classified under FDA regulations?

Accepted Answer

Veran Medical Technologies Inc.’s devices fall under Class II classification according to FDA regulations. This classification typically applies to devices that pose moderate risk and require special controls—such as performance standards, post-market surveillance, or labeling requirements—to ensure their safety and effectiveness. Class II devices are subject to premarket notification (510(k)) submissions to demonstrate compliance with these controls.

Device	Model / Reference	Registries	Class	Status
vPad2 Connector Cable	INS-0048	FDA UDI	Class II	Unknown
SPiN Access Catheter Adapter, Olympus 190	INS-5902	FDA UDI	Class II	Unknown
SPiNPlanning Laptop Workstation	SYS-0185	FDA UDI	Class II	Unknown
View Optical Probe	INS-5500	FDA UDI	Class II	Unknown
Always-On vTrack Universal Tracker, SM/CL, 12-18ga	INS-5039	FDA UDI	Class II	Unknown
SPiN EWC – Biopsy Guide Kit	INS-5700	FDA UDI	Class II	Unknown
Always-On Tip Tracked Brush, 15mm L, 1.8mm OD	INS-0352	FDA UDI	Class II	Unknown
17ga LG, 73mm Always-On Tip Tracked Biopsy Needle, Chiba Point	INS-5035	FDA UDI	Class II	Unknown
Always-On Tip Tracked 21ga ANSO Cytology Needle, 12mm L, 1.8mm OD	INS-0392	FDA UDI	Class II	Unknown
17ga, 105mm Always-On Tip Tracked Biopsy Needle, Chiba Point	INS-5017	FDA UDI	Class II	Unknown
0.016" Stylet, 1235mm L	INS-5411	FDA UDI	Class II	Unknown
SPiN Vision Scope, 4.0mm OD, 2.0mm WC	INS-7100	FDA UDI	Class II	Unknown
19 UTW, 105mm Always-On Tip Tracked Biopsy Needle, Chiba Point	INS-5029	FDA UDI	Class II	Unknown
18ga, 100mm Always-On Tip Tracked Biopsy Needle, Chiba Point	INS-5026	FDA UDI	Class II	Unknown
vPad2 Patient Tracker	INS-0050	FDA UDI	Class II	Unknown
19 UTW, 45mm Always-On Tip Tracked Biopsy Needle, Chiba Point	INS-5030	FDA UDI	Class II	Unknown
Always-On Tip Tracked Triple Needle Brush, 12mm L, 1.8mm OD	INS-5300	FDA UDI	Class II	Unknown
17ga, 60mm Always-On Tip Tracked Biopsy Needle, Chiba Point	INS-5022	FDA UDI	Class II	Unknown
SPiN EWC – 90 degrees w/Locking Device, Olympus	INS-5460	FDA UDI	Class II	Unknown
SPiN Access Catheter Always-On Tip Tracked Guidewire	INS-5950	FDA UDI	Class II	Unknown
19 UTW, 60mm Always-On Tip Tracked Biopsy Needle, Chiba Point	INS-5033	FDA UDI	Class II	Unknown
SPiN Thoracic Navigation System	K170023	FDA 510(k)	Class II	Active
Ig4 Image Guided System	K060903	FDA 510(k)	Class II	Active
Ig4 Image Guided System, Model: Sys-0200	K093146	FDA 510(k)	Class II	Active
Ig 4 Image Guided System	K093995	FDA 510(k)	Class II	Active
Spin Drive Always-On Tip Tracked Steerable Catheter Always-On Tip Tracked Sheath Always-On Tip Tracked Aspiration Needle	K122106	FDA 510(k)	Class II	Active
SPiN Vision Video Bronchoscope System	K202346	FDA 510(k)	Class II	Active
Ig4 Endobronchial, Model Sys-0200, Navigation Guidewire (accessory To Ig4 Endobronchial), Model Ins-0300	K091934	FDA 510(k)	Class II	Active

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