Reach Needle
FDA 510(k) clearance K240253 · decided 2024-03-21
Clearance details
- K-number
- K240253
- Device name
- Reach Needle
- Applicant
- Aerin Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-01-30
- Decision date
- 2024-03-21
- Days to decision
- 51 days
- Clearance type
- Traditional
- Product code
- BSP
- Device class
- 2
- Regulation number
- 868.5150
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Mountain View,, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.