TX1 TISSUE REMOVAL SYSTEM
FDA 510(k) clearance K123640 · decided 2013-03-20
Clearance details
- K-number
- K123640
- Device name
- TX1 TISSUE REMOVAL SYSTEM
- Applicant
- Tenex Health
- Decision
- Substantially Equivalent
- Date received
- 2012-11-26
- Decision date
- 2013-03-20
- Days to decision
- 114 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. TX1 Procedure Pack P/N 554-1003-001 (outer box), TX1 MicroTip P recall (Z-1552-2014) | Tenex Health Inc | 2014-05-06 |