Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology
FDA 510(k) clearance K170456 · decided 2017-04-05
Clearance details
- K-number
- K170456
- Device name
- Reprocessed HARMONIC FOCUS Shears + Adaptive Tissue Technology
- Applicant
- Stryker Sustainability Solutions
- Decision
- Substantially Equivalent
- Date received
- 2017-02-15
- Decision date
- 2017-04-05
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- NLQ
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Tempe, AZ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| HARMONIC FOCUS Shears + Adaptive Tissue Technology, 9 cm Length REF: HAR9F, Reprocessed De recall (Z-0490-2026) | Stryker Sustainability Solutions | 2025-11-12 |