TX1 TISSUE REMOVAL SYSTEM— 510(k) K101561
Substantially EquivalentAmerican Optisurgical, Inc.
FDA 510(k) clearance K101561 for TX1 TISSUE REMOVAL SYSTEM, Substantially Equivalent on 2010-08-27. Applicant: American Optisurgical, Inc.. Device class: Unclassified.
Clearance details
- Applicant
- American Optisurgical, Inc.
- Product code
- Code LFL
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lake Forest, CA, US
Recent devices under product code LFL
view allMore clearances from American Optisurgical, Inc.
view allAdverse events under product code LFL
product code LFL- Death
- 29
- Injury
- 1,046
- Malfunction
- 21,642
- Total
- 22,717
Source: openFDA MAUDE database, through . 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 K101561
K-number listed on FDA's recall record- Z-1516-2013 — American Optisurgical's TX1 Tissue Removal System Console. The console is a software unit that is indicated for use in surgical procedures.
- Z-1817-2012 — 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 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.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K101561.
Data sourced from openFDA. This site is unofficial and independent of the FDA.