The following data is part of a premarket notification filed by Tenex Health, Inc. with the FDA for Tenex Health Tx System With The Txp Microtip.
| Device ID | K181367 |
| 510k Number | K181367 |
| Device Name: | Tenex Health TX System With The TXP MicroTip |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | Tenex Health, Inc. 26902 Vista Terrace Lake Forest,, CA 92630 |
| Contact | David Vancelette |
| Correspondent | David Vancelette Tenex Health, Inc. 26902 Vista Terrace Lake Forest,, CA 92630 |
| Product Code | LFL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-23 |
| Decision Date | 2018-08-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857156006123 | K181367 | 000 |
| 00857156006338 | K181367 | 000 |
| 00857156006109 | K181367 | 000 |
| 00857156006079 | K181367 | 000 |
| 00857156006406 | K181367 | 000 |