Harmonic Focus Shears
510(k) K100597
Harmonic Focus Shears is a device classified as Unclassified made by Ethicon Endo-Surgery, LLC, cleared under FDA 510(k) K100597 on 7 Apr 2010, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK100597 | Date7 Apr 2010 | StatusActive |
Official records
- FDA 510(k) database K100597
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LFL
- Device class
- U
- Advisory committee
- Unknown
- FDA decision
- SESE Substantially Equivalent
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