Data / Medical devices / United States / Tenex Health
Tenex Health: FDA-registered device maker in Lake Forest, CA, United States, 3 510(k) clearances
Tenex Health is registered with the FDA (registration 3009750704) in Lake Forest, CA, United States. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated August 28, 2018. 6 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009750704
- FEI number
- 1000135560
- Address
- 26902 Vista Terrace, Lake Forest, CA, United States, 92630
- Owner or operator
- Tenex Health (10042896)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- September 3, 2013
- Registered through
- 2026
- Brand names listed
- TX Supply Kit, TX System Console, TX-Bone, TX-DFU Procedure Pack, TX1 MicroTip, TX1 Procedure Pack, TX1 Tissue Removal System, TX2 MicroTip and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Instrument, Ultrasonic Surgical | LFL | U | Contract manufacturer, 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, 2018 | K181367 | Tenex Health TX System with the TXP MicroTip | LFL | Substantially Equivalent | Tenex Health, Inc. | accessdata.fda.gov |
| March 3, 2016 | K153299 | Tenex Health TX System | LFL | Substantially Equivalent | Tenex Health, Inc. | accessdata.fda.gov |
| March 20, 2013 | K123640 | TX1 TISSUE REMOVAL SYSTEM | LFL | Substantially Equivalent | Tenex Health | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 14, 2014 | 68074 | Class II | Terminated | TX1 Tissue Removal System. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip P/N 554-1002-001 (inner tray). For use with the TX System Console as an ultrasonic surgical aspirator of soft tissue. | The sterile barrier in the packaging may be compromised due to cracks in the thermoform tray that may occur during transport of the product in extreme cold weather conditions, in conjunction with mechanical impact. | accessdata.fda.gov |
| April 30, 2013 | 65108 | Class II | Terminated | TX1 Tissue Removal System disposable handpieces. Product Usage: The TX1 Tissue Removal System is indicated for use in surgical procedures where fragmentation, emulsification and aspiration of soft tissue are desirable, i | American Optisurgical, Inc. is recalling certain lots of TX1 Tissue Removal System disposable handpiece due to inventory being released into distribution without a cleared FDA 510(k) to cover recent product changes. Use of this product may lead to an underperformance of the device. | accessdata.fda.gov |
| April 30, 2013 | 65098 | Class II | Terminated | FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray. | American Optisurgical, Inc initiated a recall of ChloraPrep Hi-Lite Orange 3mL Applicator, in response to a sub-recall letter from Medline Industries, Inc due to lack of sterility assurance caused by an incomplete seal on the individual unit packaging. | accessdata.fda.gov |
| March 30, 2013 | 65113 | Class II | Terminated | American Optisurgical's TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in surgical procedures. | The recall has been initiated due to an overheating protection voltage suppressor on the redundant safety protection circuit board. Secondary to the recall, American Optisurgical, Inc. will be making a correction to add spacers between the valve and cassette to correct a small irrigation leak that can occur after the priming cycle. Use of this product may ca | accessdata.fda.gov |
| February 22, 2012 | 61253 | Class II | Terminated | TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is an ultrasonic aspirator that emulsifies and removes soft tissue. The TX1 Console provides control over each mode of operation, as well as the use | Two reasons for recall. 1. Incorrect pressure relief valve installed inside console, leading to a remote chance of a risk to health. 2. Technical Specifications, under Irrigation, the Operating Pressure value is incorrect. | accessdata.fda.gov |
| March 24, 2009 | 52697 | Not yet classified | Terminated | American Optisurgical, Horizon Phacoemulsification System, Model: HZN-2030, for ophthalmic surgery. | Device operation interrupted: A software bug causes Phaco to stop when vacuum goes above 300 mmHg while in Multi Burst mode. Use of this product at the parameters specified above could lead to a delay in surgery that might present a health risk. | accessdata.fda.gov |
Compare with other makers
Updated August 28, 2018. 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.