Nuvis Battery Arthroscope
FDA 510(k) clearance K191594 · decided 2019-07-11
Clearance details
- K-number
- K191594
- Device name
- Nuvis Battery Arthroscope
- Applicant
- Integrated Endoscopy, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2019-06-17
- Decision date
- 2019-07-11
- Days to decision
- 24 days
- Clearance type
- Special
- Product code
- HRX
- Device class
- 2
- Regulation number
- 888.1100
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.