The following data is part of a premarket notification filed by Ethicon Endo-suregery, Llc with the FDA for Harmonic Hd 1000i Shears 20 Cm Length, Harmonic Hd 1000i Shears 36 Cm Length.
| Device ID | K160752 |
| 510k Number | K160752 |
| Device Name: | HARMONIC HD 1000i Shears 20 Cm Length, HARMONIC HD 1000i Shears 36 Cm Length |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | ETHICON ENDO-SUREGERY, LLC 475 CALLE C Guaynabo, PR 00969 |
| Contact | Marjorie Medina |
| Correspondent | David Locke ETHICON ENDO-SURGERY, LLC 475 Calle C Guaynabo, PR 00969 |
| 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 | 2016-03-18 |
| Decision Date | 2016-06-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705036015052 | K160752 | 000 |
| 20705036015045 | K160752 | 000 |
| 10705036015055 | K160752 | 000 |
| 10705036015048 | K160752 | 000 |