The following data is part of a premarket notification filed by Tenex Health with the FDA for Tx1 Tissue Removal System.
Device ID | K123640 |
510k Number | K123640 |
Device Name: | TX1 TISSUE REMOVAL SYSTEM |
Classification | Instrument, Ultrasonic Surgical |
Applicant | TENEX HEALTH 26902 VISTA TERRACE Lake Forest, CA 92630 |
Contact | David Salzberg |
Correspondent | David Salzberg TENEX HEALTH 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 | 2012-11-26 |
Decision Date | 2013-03-20 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00857156006246 | K123640 | 000 |
00857156006086 | K123640 | 000 |
00857156006208 | K123640 | 000 |
00857156006222 | K123640 | 000 |
00857156006260 | K123640 | 000 |
00857156006277 | K123640 | 000 |
00857156006291 | K123640 | 000 |
00857156006307 | K123640 | 000 |
00857156006314 | K123640 | 000 |
00857156006321 | K123640 | 000 |
00857156006352 | K123640 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
TX1 TISSUE REMOVAL SYSTEM 85599103 not registered Dead/Abandoned |
Tenex Health, Inc. 2012-04-16 |