Data / Medical devices / United States / Lexion Medical, LLC.
Lexion Medical, LLC.: FDA-registered device maker in Saint Paul, MN, United States, 4 510(k) clearances
Lexion Medical, LLC. is registered with the FDA (registration 2135348) in Saint Paul, MN, United States. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated August 28, 2019. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 2135348
- FEI number
- 3003631551
- Address
- 545 Atwater Cir, Saint Paul, MN, United States, 55103
- Owner or operator
- LEXION MEDICAL, LLC. (9044154)
- Roles
- Manufacturer
- First device listed
- December 12, 2007
- Registered through
- 2026
- Brand names listed
- 4100-10 INSUFLOW PORT, 4100-10-XE INSUFLOW PORT, 4100-10B INSUFLOW PORT, 4100-10B-XE INSUFLOW PORT, 4100-12 INSUFLOW PORT, 4100-12-XE INSUFLOW PORT, 4100-12B INSUFLOW PORT, 4100-12B-XE INSUFLOW PORT and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Insufflator, Endoscopic Vessel Harvesting | OSV | 2 | Manufacturer | accessdata.fda.gov |
| Insufflator, Laparoscopic | HIF | 2 | Manufacturer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Manufacturer | accessdata.fda.gov |
| Tube, Smoke Removal, Endoscopic | FCZ | 1 | Manufacturer | accessdata.fda.gov |
| Tubing/Tubing With Filter, Insufflation, Laparoscopic | NKC | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 28, 2019 | K191780 | AP50/30 Insufflator with Insuflow Port | HIF | Substantially Equivalent | Lexion Medical, LLC | accessdata.fda.gov |
| November 14, 2017 | K170799 | AP 50/30 Insufflator with Insuflow Port | HIF | Substantially Equivalent | Lexion Medical, LLC | accessdata.fda.gov |
| September 27, 2010 | K102136 | VESSEL GUARDIAN | HIF | Substantially Equivalent | Lexion Medical, LLC | accessdata.fda.gov |
| January 10, 2007 | K063546 | INSUFLOW DEVICE, MODEL 6198 | HIF | Substantially Equivalent | Lexion Medical, LLC | accessdata.fda.gov |
Compare with other makers
- All makers of Tubing/Tubing With Filter, Insufflation, Laparoscopic
- All makers of Insufflator, Laparoscopic
- All makers of Laparoscope, General & Plastic Surgery
- All makers of Insufflator, Endoscopic Vessel Harvesting
- All makers of Tube, Smoke Removal, Endoscopic
Updated August 28, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.