Entellus Medical Reinforced Anesthesia Needle
FDA 510(k) clearance K163435 · decided 2017-04-05
Clearance details
- K-number
- K163435
- Device name
- Entellus Medical Reinforced Anesthesia Needle
- Applicant
- Entellus Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-12-07
- Decision date
- 2017-04-05
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- BSP
- Device class
- 2
- Regulation number
- 868.5150
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.