The following data is part of a premarket notification filed by Lexion Medical, Llc. with the FDA for Insuflow Synergy Port, Insuflow Synergy Xl Port.
| Device ID | K140263 |
| 510k Number | K140263 |
| Device Name: | INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORT |
| Classification | Insufflator, Laparoscopic |
| Applicant | LEXION MEDICAL, LLC. 4486 TIMBERLINE CT Vadnais Heights, MN 55127 |
| Contact | Bernard Horwath |
| Correspondent | Bernard Horwath LEXION MEDICAL, LLC. 4486 TIMBERLINE CT Vadnais Heights, MN 55127 |
| Product Code | HIF |
| CFR Regulation Number | 884.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-03 |
| Decision Date | 2014-03-05 |
| Summary: | summary |