FDA Registration
Active
🇺🇸 United States
LEXION MEDICAL, LLC.
Reg #: 2135348
·
FEI: 3003631551
·
Expires 2026
Products
5
Proprietary Names
30
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- LEXION MEDICAL, LLC.
- Registration Number
- 2135348
- FEI Number
- 3003631551
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 545 Atwater Cir
- City
- Saint Paul
- State
- MN
- ZIP
- 55103
- Country
- US
Regulatory Submissions
- 510(k) Number
- K063546
Owner / Operator
- Firm Name
- LEXION MEDICAL, LLC.
- Operator Number
- 9044154
- Address
- 545 Atwater Circle, --
- City
- Saint Paul
- State
- MN
- Postal Code
- 55103
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Insufflator, Laparoscopic | HIF | Class 2 | Obstetrics/Gynecology | No | 2007-12-12 |
| Laparoscope, General & Plastic Surgery | GCJ | Class 2 | Gastroenterology, Urology | No | 2023-08-16 |
| Insufflator, Endoscopic Vessel Harvesting | OSV | Class 2 | Obstetrics/Gynecology | No | 2023-08-16 |
| Tube, Smoke Removal, Endoscopic | FCZ | Class 1 | Gastroenterology, Urology | No | 2008-01-30 |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | NKC | Class 1 | Obstetrics/Gynecology | No | 2007-12-12 |
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
Vessel Guardian
Establishment Types
Manufacture Medical Device