Question 1

What types of medical devices does Cogentix Medical, Inc. manufacture?

Accepted Answer

Cogentix Medical, Inc. specializes in reusable flexible video cystoscopes, which are used in urological procedures. They also produce disposable optical medical device procedural covers to improve sterility and reduce contamination risks. Additionally, the company manufactures endoscopic video image processing units that enhance visualization during minimally invasive surgeries, along with a variety of EndoSheath Technology products designed to sheath cystoscopes and other endoscopic instruments.

Question 2

Where is Cogentix Medical, Inc. based?

Accepted Answer

Cogentix Medical, Inc. is headquartered in the United States. The company’s location influences its regulatory compliance, particularly with the FDA’s requirements for medical devices marketed in the US.

Question 3

Which regulatory registries list Cogentix Medical, Inc.’s devices?

Accepted Answer

Cogentix Medical, Inc.’s devices are listed in multiple regulatory databases, including the EU’s eudamed registry and the FDA’s 510(k) clearance database in the US. They are also included in the FDA’s Unique Device Identifier (UDI) system, ensuring traceability and compliance with medical device regulations in both markets.

Question 4

How are Cogentix Medical, Inc.’s devices classified under medical device regulations?

Accepted Answer

Cogentix Medical, Inc.’s devices fall under different classification tiers depending on their intended use and risk level. Most of their products are classified as Class I (low-risk devices) or Class II/Class IIa (moderate-risk devices), which requires compliance with specific FDA and EU regulatory requirements. For example, reusable cystoscopes and video processors may carry higher classification due to their procedural role, while disposable procedural covers are typically lower risk.

Question 5

Why do some of Cogentix Medical, Inc.’s devices appear in the FDA’s 510(k) database?

Accepted Answer

The FDA’s 510(k) database includes devices that have undergone a 510(k) premarket notification process, which demonstrates that the device is substantially equivalent to a legally marketed predicate device. This process ensures that Cogentix Medical, Inc.’s devices meet FDA safety and effectiveness standards before commercialization in the US. Not all devices require 510(k) clearance—some may fall under exemptions or other regulatory pathways—but those listed have undergone this review.

Device	Model / Reference	Registries	Class	Status
Flexible Fiber Laryngoscope, Standard Set Reconditioned	ENT-4000	FDA UDI	Class II	Unknown
Unity 9100	UVP-9100	FDA UDI	Class II	Active
EndoSheath Technology	TV-2.1	FDA UDI	Class II	Active
Flexible Video Laryngoscope (NTSC) Reconditioned	ENT-5000	FDA UDI	Class II	Unknown
Unity 9000	UVP-9000	FDA UDI	Class II	Active
Flexible Video Laryngoscope (NTSC) Reconditioned	ENT-7000	FDA UDI	Class II	Unknown
Video Processor	DPU-5050A	FDA UDI	Class II	Unknown
Flexible Fiber Laryngoscope, Standard Set	ENT-4500	FDA UDI	Class II	Unknown
EndoSheath Technology	BVX-2.8	FDA UDI	Class II	Active
EndoSheath Technology	BF-2.1	FDA UDI	Class II	Active
Video Processor	DPU-5050A	FDA UDI	Class II	Unknown
Flexible Video Laryngoscope (NTSC)	ENT-5000	FDA UDI	Class II	Unknown
Nasal Cytology Brush	07-9006	FDA UDI	Class II	Unknown
Video Processor	DPU-7000A	FDA UDI	Class II	Active
EndoSheath Technology	BV-1.5	FDA UDI	Class II	Active
EndoSheath Technology	BVX-0	FDA UDI	Class II	Active
Flexible Video Esophagoscope (NTSC) Reconditioned	TNE-5000	FDA UDI	Class II	Unknown
EndoSheath Technology	BV-2.1	FDA UDI	Class II	Active
Endoscopic Cytology Brush	07-9001	FDA UDI	Class II	Unknown
EndoSheath Technology	BF-2.8	FDA UDI	Class II	Active
Flexible Video Bronchoscope (NTSC)	BRS-5100	FDA UDI	Class II	Unknown
Flexible Fiber Laryngoscope, Standard Set Reconditioned	ENT-4500	FDA UDI	Class II	Unknown
Flexible Video Laryngoscope (NTSC)	ENT-7000	FDA UDI	Class II	Unknown
Flexible Fiber Bronchoscope	BRS-4000	FDA UDI	Class II	Unknown
Flexible Video Cystoscope (NTSC)	CST-5000S	FDA UDI	Class II	Active
Flexible Fiber Laryngoscope, Standard Set	ENT-4000	FDA UDI	Class II	Unknown
EndoSheath Technology	TV-1.5	FDA UDI	Class II	Active
Flexible Video Esophagoscope (NTSC)	TNE-5000	FDA UDI	Class II	Unknown
EndoSheath Technology	BVX-2.1	FDA UDI	Class II	Active
EndoSheath Technology	BF-0	FDA UDI	Class II	Active
Video Processor	DPU-7000A	FDA UDI	Class II	Active
Flexible Video Cystoscope (NTSC) Intuitive	CST-5000iS	FDA UDI	Class II	Active
EndoSheath Technology	BF-1.5	FDA UDI	Class II	Active
Flexible Video Cystoscope (NTSC) Reconditioned	CST-5000	FDA UDI	Class II	Active
Flexible Video Bronchoscope (NTSC) Reconditioned	BRS-5100	FDA UDI	Class II	Unknown
Flexible Video Cystoscope (NTSC) Intuitive Reconditioned	CST-5000i	FDA UDI	Class II	Active
Endoscopic Injection Needle	07-9005	FDA UDI	Class II	Unknown
EndoSheath Technology	BV-0	FDA UDI	Class II	Active
EndoSheath Technology	BVX-1.5	FDA UDI	Class II	Active
CST-5000 Series Video Cystoscope/Hysteroscope, PAL	08-5202	EUDAMED	Class IIa	Active
PrimeSight™ UNITY 9000 Video Processor, PrimeSight™ UNITY 9100 Video Processor	K181292	FDA 510(k)	Class II	Active
PrimeSight UltraView System	K253905	FDA 510(k)	Class II	Active
Endoscope Light Guide Sleeve - Circon	06-6019	EUDAMED	Class I	Active
Fiberoptic Light Cable	07-3060	EUDAMED	Class I	Active
EndoSheath Protective Barrier	CV 2.1	EUDAMEDFDA UDI	Class I	Active
Unity 9000 Digital Video Processor	07-9000	EUDAMED	Class I	Active
Detachable Light Guide Cable, 2.5M	07-3062	EUDAMED	Class I	Active
EndoSheath Protective Barrier	CV 1.5	EUDAMEDFDA UDI	Class I	Active
BLS-1000 Battery Light Source Replacement	07-3050	EUDAMEDFDA UDI	Class I	Active
Endoscope Light Guide Sleeve - Wolf	06-6020	EUDAMED	Class I	Active

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