Sparrow Therapy System
FDA 510(k) clearance K201873 · decided 2021-01-02
Clearance details
- K-number
- K201873
- Device name
- Sparrow Therapy System
- Applicant
- Spark Biomedical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-07-07
- Decision date
- 2021-01-02
- Days to decision
- 179 days
- Clearance type
- Traditional
- Product code
- PZR
- Device class
- 2
- Regulation number
- 882.5896
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Dallas, TX, 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.
| Record | Firm | Date |
|---|---|---|
| Sparrow Ascent (K251246) | Spark Biomedical, Inc. | 2025-08-25 |
| NET Recovery Corp/NET Device (K233166) | Net Recovery | 2024-05-29 |
| Sparrow Ascent (K230796) | Spark Biomedical, Inc. | 2023-06-20 |
| Drug Relief v1 (K221231) | Dyansys, Inc. | 2022-06-06 |
| Drug Relief v1 (K211971) | Dyansys, Inc. | 2021-11-05 |
| Drug Relief (K173861) | Dyansys, Inc. | 2018-05-02 |
| NSS-2 System (DEN170018) | Innovative Health Solutions (Ihs), Inc. | 2017-11-15 |
Recalls involving this device
No recalls on record reference this clearance.