RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles
FDA 510(k) clearance K203668 · decided 2021-09-29
Clearance details
- K-number
- K203668
- Device name
- RELI NRFit Epidural Needles, Phoenix NRFit Epidural Needles, RELI NRFit Spinal Needles, Phoenix NRFit Spinal Needles
- Applicant
- Myco Medical Supplies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-12-16
- Decision date
- 2021-09-29
- Days to decision
- 287 days
- Clearance type
- Traditional
- Product code
- BSP
- Device class
- 2
- Regulation number
- 868.5150
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Apex, NC, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.