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Lexion Medical LLC

United States·US-MF-000033626

Last updated May 30, 2026

What Lexion Medical LLC makes

Lexion Medical LLC produces single-use insufflation tubing sets and related accessories for endoscopic procedures, including filtered tube sets and specialized ports for bariatric applications. Their portfolio also includes insufflation devices, gas evacuation cannulas, and insufflator attachments designed for controlled gas delivery during minimally invasive surgeries. Examples include the Insuflow series, Vessel Guardian tubing, and the PneuView XE cannula, which are tailored for various procedural needs. The company offers both standard and modified configurations to accommodate different patient sizes and surgical requirements.

The company’s devices are classified under FDA regulations as Class I or Class II (including Class IIa), reflecting varying levels of risk and regulatory oversight. These products are listed in the FDA’s 510(k) and UDI registries, as well as in the EU’s eudamed database, ensuring compliance with both U.S. and European medical device regulations. Lexion Medical LLC is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: United States
Address: 545, Atwater Circle, ST. PAUL, United States
Website: www.lexionmedical.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 6516350000
PRRC Contact: Sean Hawthorne
EUDAMED SRN: US-MF-000033626
FDA FEI Number: —
DUNS Number: 848693730

Catalogue (37)

Device	Model / Reference	Registries	Class	Status
Vessel Guardian	1117	FDA UDI	Class II	Active
Insuflow	6198NS	FDA UDI	Class II	Unknown
Insuflow	PP1000NS	FDA UDI	Class II	Unknown
Insuflow Synergy Xl Port	1991-12B	FDA UDI	Class II	Unknown
iNSUFLOW SYNERGY XL PORT	1991-10B	FDA UDI	Class II	Unknown
Insuflow Synergy Xl Port	1991-10	FDA UDI	Class II	Unknown
Insuflow Synergy Xl Port	1991-8	FDA UDI	Class II	Unknown
Veryclear	1515	FDA UDI	Class II	Unknown
Insuflow Synergy Xl Port	1991-8B	FDA UDI	Class II	Unknown
Pneuview Xe	9660-XENS	FDA UDI	Class I	Unknown
Insuflow Synergy Xl Port	1991-12	FDA UDI	Class II	Unknown
Insuflow	6198	FDA UDI	Class II	Active
Insuflow	6198M	FDA UDI	Class II	Unknown
Insuflow Synergy Port	1991	FDA UDI	Class II	Unknown
Standard filtered tube set	4100-SHT	FDA UDI	Class I	Active
Insuflow Port 10mm Bariatric	4100-10B	EUDAMEDFDA UDI	Class IIa	Active
Insuflow Port 5mm	4100-5	EUDAMEDFDA UDI	Class IIa	Active
Insuflow Device, Model 6198	K063546	FDA 510(k)	Class II	Active
Insuflow Synergy Port, Insuflow Synergy Xl Port	K140263	FDA 510(k)	Class II	Active
Vessel Guardian	K102136	FDA 510(k)	Class II	Active
Pneuview Xe Veryclear Gas Evacuation Cannula	K132203	FDA 510(k)	Class II	Active
Vasovapor	K101320	FDA 510(k)	Class II	Active
AP 50/30 Insufflator with Insuflow Port	K170799	FDA 510(k)	Class II	Active
Vessel Guardian	K112357	FDA 510(k)	Class II	Active
Insuflow Co2ionshield	K090879	FDA 510(k)	Class II	Active
Insuflow Synergy Xl Port	K132204	FDA 510(k)	Class II	Active
Insuflow Synergy Port	K120640	FDA 510(k)	Class II	Active
Insuflow Dewheart	K091366	FDA 510(k)	Class II	Active
AP50/30 Insufflator with Insuflow Port	K191780	FDA 510(k)	Class II	Active
Insuflow Port 10mm	4100-10	EUDAMEDFDA UDI	Class IIa	Active
Insuflow Port 8mm	4100-8	EUDAMEDFDA UDI	Class IIa	Active
Insuflow Port 5mm Bariatric	4100-5B	EUDAMEDFDA UDI	Class IIa	Active
PneuView XE	9660-XE	EUDAMEDFDA UDI	Class I	Active
AP50/30 High-Flow Insufflator	4100	EUDAMEDFDA UDI	Class IIa	Active
Insuflow Port 8mm Bariatric	4100-8B	EUDAMEDFDA UDI	Class IIa	Active
Insuflow Port 12mm	4100-12	EUDAMEDFDA UDI	Class IIa	Active
Insuflow Port 12mm Bariatric	4100-12B	EUDAMEDFDA UDI	Class IIa	Active

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