TX1 TISSUE REMOVAL SYSTEM— 510(k) K123640

Name: FDA 510(k) clearance K123640
Creator: U.S. Food and Drug Administration
Published: 2013-03-20

Substantially Equivalent

Tenex Health

FDA 510(k) clearance K123640 for TX1 TISSUE REMOVAL SYSTEM, Substantially Equivalent on 2013-03-20. Applicant: Tenex Health. Device class: Unclassified.

Clearance details

Applicant: Tenex Health
Product code: Code LFL
Device class: Unclassified
Advisory panel: Unknown
Date received: 2012-11-26
Decision date: 2013-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Forest,, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LFL

view all

K261448 — neXus Ultrasonic Surgical Aspirator System2026-07-30
K251162 — CUSA® Clarity Ultrasonic Surgical Aspirator System2025-10-08
K242894 — SanAgile Ultrasonic Surgery Advanced Portable Controller (SA10) +4 more2025-06-18
K243930 — Sonopet iQ Ultrasonic Aspirator System (5500-050-000)2025-03-24
K241700 — Tenex 2nd Generation System2024-11-18

Adverse events under product code LFL

product code LFL

Death: 29
Injury: 1,046
Malfunction: 21,642
Total: 22,717

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K123640

K-number listed on FDA's recall record

Z-1552-2014 — 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.Class II·Terminated·Tenex Health Inc·20140414

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123640.

Data sourced from openFDA. This site is unofficial and independent of the FDA.