TZ SKULL PIN Adult
FDA 510(k) clearance K163322 · decided 2017-02-23
Clearance details
- K-number
- K163322
- Device name
- TZ SKULL PIN Adult
- Applicant
- Tz Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-11-25
- Decision date
- 2017-02-23
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- HBL
- Device class
- 2
- Regulation number
- 882.4460
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Portland, OR, 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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| TZ Medical Defibrillation Electrodes, Accessory Cables, and Connectors (P200005) | Tz Medical, Inc. | 2024-01-09 |