510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Tenex Health

Lake Forest, CA, US

TENEX HEALTH appears in FDA device records in Lake Forest, CA. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 6 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
9
PMA records
0
Recall records
6
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to Tenex Health carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • American Optisurgical, Inc.510(k), enforcement report, recall

510(k) clearance history

FDA records hold 9 510(k) clearances for Tenex Health between 1995 and 2018. The busiest year on record is 1995, with 3. The most recent is 2018, with 1.

Clearances by year, as a table
510(k) clearance decisions for Tenex Health, by decision year
YearClearances
19953
20021
20081
20101
20131
20161
20181
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K181367Tenex Health TX System with the TXP MicroTipLFLSubstantially Equivalent
K153299Tenex Health TX SystemLFLSubstantially Equivalent
K123640TX1 TISSUE REMOVAL SYSTEMLFLSubstantially Equivalent
K101561TX1 TISSUE REMOVAL SYSTEMLFLSubstantially Equivalent
K080803VISUAL PHACOEMULSIFICATION SYSTEM, MODEL 551HQCSubstantially Equivalent
K020527HORIZON PHACOEMULSIFICATION SYSTEM, MODEL HZN-2030HQCSubstantially Equivalent
K953539DM001 DISPOSABLE PACKHQCSubstantially Equivalent
K953538RM001 REUSABLEHQCSubstantially Equivalent
K952331AOI LC-40 PHACOEMULSIFIERHQCSubstantially Equivalent

Registered establishments

FDA registered establishments for Tenex Health, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30097507041000135560TENEX HEALTH26902 Vista Terrace, Lake Forest, CA 92630 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1552-2014TX1 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.Class IITerminated
Z-1518-2013TX1 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, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.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.Class IITerminated
Z-1505-2013FAST 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.Class IITerminated
Z-1516-2013American 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 cause the device to lose power and stop woClass IITerminated
Z-1817-2012TX1 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 user interface via LCD touchscreen and audible tones for confirmation of user selections. Indiciated for use in surgical procedures where fragmentation, emulsification, and aspiration of soft tissue are desirable, including General Surgery, Orthopedic Surgery, Laparoscopic Surgery and Plastic and Reconstructive Surgery.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.Class IITerminated
Z-1808-2009American 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.Terminated

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Data as of , FDA export datePage updated Source: openFDA, public domain