HARMONIC FOCUS SHEARS
FDA 510(k) clearance K100597 · decided 2010-04-07
Clearance details
- K-number
- K100597
- Device name
- HARMONIC FOCUS SHEARS
- Applicant
- Ethicon Endo-Surgery, LLC
- Decision
- Substantially Equivalent
- Date received
- 2010-03-02
- Decision date
- 2010-04-07
- Days to decision
- 36 days
- Clearance type
- Traditional
- Product code
- LFL
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Cincinnati, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.