The following data is part of a premarket notification filed by Ethicon Endo-surgery, Llc with the FDA for Harmonic Hd 1000i Shears, 20 Cm Length, Harmonic Hd 1000i Shears, 36 Cm Length.
| Device ID | K191555 |
| 510k Number | K191555 |
| Device Name: | HARMONIC HD 1000i Shears, 20 Cm Length, HARMONIC HD 1000i Shears, 36 Cm Length |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | Ethicon Endo-Surgery, LLC 475 Calle C Guaynabo, PR 00969 |
| Contact | Nathan Anderson |
| Correspondent | Brian Godwin Ethicon Endo-Surgery, Inc. 4545 Creek Road, ML39 Cincinnati, OH 45242 |
| Product Code | LFL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-12 |
| Decision Date | 2020-02-28 |