510(k) K191555
K191555 is an FDA 510(k) premarket notification submitted by Ethicon Endo-Surgery, LLC for the device "HARMONIC HD 1000i Shears, 20 cm length, HARMONIC HD 1000i Shears, 36 cm length". The FDA issued a decision of Substantially Equivalent on Feb 28, 2020. The device falls under product code LFL (Instrument, Ultrasonic Surgical), a Class U device. Ethicon Endo-Surgery, LLC has 183 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 28, 2020
- Date Received
- Jun 12, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Ultrasonic Surgical
- Device Class
- Class U
- Review Panel
- SU
- Submission Type
- 510(k)