The following data is part of a premarket notification filed by Ethicon Endo-surgery, Llc with the FDA for Harmonic Scallop Blade, Generator G11.
| Device ID | K141122 |
| 510k Number | K141122 |
| Device Name: | HARMONIC SCALLOP BLADE, GENERATOR G11 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | ETHICON ENDO-SURGERY, LLC 4545 CREEK ROAD Cincinnati, OH 45242 |
| Contact | Emily Kruetzkamp |
| Correspondent | Emily Kruetzkamp ETHICON ENDO-SURGERY, LLC 4545 CREEK ROAD 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 | 2014-04-30 |
| Decision Date | 2014-09-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30705036014571 | K141122 | 000 |