The following data is part of a premarket notification filed by Ethicon Endo-surgery, Llc with the FDA for Harmonic 1100 Shears, 20cm Length, Harmonic 1100 36cm Length, Generator G11.
| Device ID | K200841 |
| 510k Number | K200841 |
| Device Name: | Harmonic 1100 Shears, 20cm Length, Harmonic 1100 36cm Length, Generator G11 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Ethicon Endo-Surgery, Llc 475 Calle C Guaynabo, PR 00969 |
| Contact | Nathan Anderson |
| Correspondent | Brian Godwin Ethicon Endo-Surgery, Inc 4545 Creek Rd Cincinnati, OH 45242 |
| Product Code | GEI |
| Subsequent Product Code | HGI |
| Subsequent Product Code | LFL |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-31 |
| Decision Date | 2020-05-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705036026171 | K200841 | 000 |
| 20705036026164 | K200841 | 000 |