CUSA Excel+
FDA 510(k) clearance K150682 · decided 2015-12-18
Clearance details
- K-number
- K150682
- Device name
- CUSA Excel+
- Applicant
- Integra Lifesciences Corp.
- Decision
- Substantially Equivalent
- Date received
- 2015-03-17
- Decision date
- 2015-12-18
- Days to decision
- 276 days
- Clearance type
- Traditional
- Product code
- LFL
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Planisboro, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.