TX1 TISSUE REMOVAL SYSTEM
FDA 510(k) clearance K101561 · decided 2010-08-27
Clearance details
- K-number
- K101561
- Device name
- TX1 TISSUE REMOVAL SYSTEM
- Applicant
- American Optisurgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-06-04
- Decision date
- 2010-08-27
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- LFL
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Lake Forest, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| TX1 Tissue Removal System Console. Model: TX1 TX1 Tissue Removal System is an ultrasonic a recall (Z-1817-2012) | American Optisurgical Inc | 2013-08-08 |
| American Optisurgical's TX1 Tissue Removal System Console. The console is a software unit recall (Z-1516-2013) | American Optisurgical Inc | 2013-06-06 |