INNERVUE DIAGNOSTIC SCOPE SYSTEM
FDA 510(k) clearance K072879 · decided 2008-01-14
Clearance details
- K-number
- K072879
- Device name
- INNERVUE DIAGNOSTIC SCOPE SYSTEM
- Applicant
- Biomet Orthopedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-10-09
- Decision date
- 2008-01-14
- Days to decision
- 97 days
- Clearance type
- Traditional
- Product code
- HRX
- Device class
- 2
- Regulation number
- 888.1100
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Warsaw, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Biomet INNERVUE DISPOSABLE SCOPE KIT 1.2MM, PRODUCT NUMBER 922140, STERILE recall (Z-1588-2011) | Biomet, Inc. | 2011-03-07 |
| Biomet INNERVUE DISPOSABLE SCOPE KIT 1.2MM WITH CANNULA SET, PRODUCT NUMBER 922141, STERIL recall (Z-1589-2011) | Biomet, Inc. | 2011-03-07 |