ENDIUS SPINE ENDOSCOPE
FDA 510(k) clearance K982819 · decided 1999-01-27
Clearance details
- K-number
- K982819
- Device name
- ENDIUS SPINE ENDOSCOPE
- Applicant
- Endius, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-08-11
- Decision date
- 1999-01-27
- Days to decision
- 169 days
- Clearance type
- Traditional
- Product code
- GWG
- Device class
- 2
- Regulation number
- 882.1480
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Newton, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.