Steribite
FDA 510(k) clearance K180949 · decided 2018-11-08
Clearance details
- K-number
- K180949
- Device name
- Steribite
- Applicant
- Rjr Surgical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-04-11
- Decision date
- 2018-11-08
- Days to decision
- 211 days
- Clearance type
- Traditional
- Product code
- HAE
- Device class
- 2
- Regulation number
- 882.4840
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Cleveland, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.