TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable Antibacterial Envelope (large)
FDA 510(k) clearance K180122 · decided 2018-06-07
Clearance details
- K-number
- K180122
- Device name
- TYRX Neuro Absorbable Antibacterial Envelope (medium); TYRX Neuro Absorbable Antibacterial Envelope (large)
- Applicant
- Medtronic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-01-16
- Decision date
- 2018-06-07
- Days to decision
- 142 days
- Clearance type
- Traditional
- Product code
- FTL
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Mounds View, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.
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