LEXION MEDICAL, LLC.

FDA Device Registration & Listing · Saint Paul, MN, US · Registration 2135348

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2135348
FEI Number
3003631551
Entity Name
LEXION MEDICAL, LLC.
City/State/Country
Saint Paul, MN, US
Establishment Address
545 Atwater Cir, Saint Paul, MN 55103, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
LEXION MEDICAL, LLC. (Owner Number: 9044154)
Owner / Operator Contact Address
545 Atwater Circle, --, Saint Paul, MN 55103, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Insuflow VesselGuardian 4100-5-XE INSUFLOW PORT 4100-8B INSUFLOW PORT 4100-12B INSUFLOW PORT 4100-8-XE INSUFLOW PORT 4100-12B-XE INSUFLOW PORT AP50/30 HIGH FLOW INSUFFLATOR REF#4100 4100-8B-XE INSUFLOW PORT 4100-5 INSUFLOW PORT 4100-10B-XE INSUFLOW PORT AP50/30 HIGH FLOW INSUFFLATOR POWER CORD REF#4100-PC-ARG AP50/30 HIGH FLOW INSUFFLATOR BOTTLE GAS ADAPTER REF#4100-BG 4100-12-XE INSUFLOW PORT AP50/30 HIGH FLOW INSUFFLATOR HOUSE GAS ADAPTER REF#4100-EURO 4100-10B INSUFLOW PORT 4100-10 INSUFLOW PORT 4100-10-XE INSUFLOW PORT 4100-12 INSUFLOW PORT 4100-5B-XE INSUFLOW PORT AP50/30 HIGH FLOW INSUFFLATOR LOW PRESSURE HOSE REF#4100-LPH AP50/30 HIGH FLOW INSUFFLATOR HOUSE GAS ADAPTER REF#4100-HG 4100-8 INSUFLOW PORT 4100-5B INSUFLOW PORT Insuflow Port AP50/30 PneuVIEW PneuVIEW XE Lexion High-Flow Tube Set

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HIF Insufflator, Laparoscopic Obstetrics/Gynecology Class 2 884.1730 2007-12-12
HIF Insufflator, Laparoscopic Obstetrics/Gynecology Class 2 884.1730 2023-08-16
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2023-08-16
OSV Insufflator, Endoscopic Vessel Harvesting Obstetrics/Gynecology Class 2 884.1730 2023-08-16
HIF Insufflator, Laparoscopic Obstetrics/Gynecology Class 2 884.1730 2017-12-13
GCJ Laparoscope, General & Plastic Surgery Gastroenterology, Urology Class 2 876.1500 2017-12-13
OSV Insufflator, Endoscopic Vessel Harvesting Obstetrics/Gynecology Class 2 884.1730 2017-12-13
FCZ Tube, Smoke Removal, Endoscopic Gastroenterology, Urology Class 1 876.1500 2008-01-30
NKC Tubing/Tubing With Filter, Insufflation, Laparoscopic Obstetrics/Gynecology Class 1 884.1730 2007-12-12

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

LEXION MEDICAL, LLC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K981334 Richard Wolf Medical Instruments Corp. LAPARO CO2-PNEU (AND WITH VIDEO MONITORING) 1998-09-10
K914997 Conmedcorp ASP-IRRATOR 1992-01-07
K153773 Olympus Medical Systems Corp. Disposal Lens Cleaning Sheath 2016-11-22
K940141 Micro-Medical Devices, Inc. LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH 1994-05-19
K933812 Advanced Surgical, Inc. ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES 1993-12-13

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0027-2009 Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa 2
Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009 Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa 2
Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009 Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa 2
Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2135348. Last updated year: 2026. Please use registration number 2135348 when referencing this establishment in official correspondence.
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