The following data is part of a premarket notification filed by Soniquence, Llc with the FDA for Soniquence Bipolar Electrodes.
| Device ID | K190336 |
| 510k Number | K190336 |
| Device Name: | Soniquence Bipolar Electrodes |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Soniquence, LLC 2473 Grand Avenue Baldwin, NY 11510 |
| Contact | Suzanne Lucas |
| Correspondent | Suzanne Lucas Soniquence, LLC 2473 Grand Avenue Baldwin, NY 11510 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-14 |
| Decision Date | 2019-06-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810026181498 | K190336 | 000 |
| 00810026181290 | K190336 | 000 |
| 00810026181283 | K190336 | 000 |
| 00810026181276 | K190336 | 000 |
| 00810026181269 | K190336 | 000 |
| 00810026181252 | K190336 | 000 |
| 00810026181245 | K190336 | 000 |
| 00810026181238 | K190336 | 000 |
| 00810026181221 | K190336 | 000 |
| 00810026181214 | K190336 | 000 |
| 00810026181207 | K190336 | 000 |
| 00810026181825 | K190336 | 000 |
| 00810026181740 | K190336 | 000 |
| 00810026181528 | K190336 | 000 |
| 00810026181306 | K190336 | 000 |
| 00810026181313 | K190336 | 000 |
| 00810026181320 | K190336 | 000 |
| 00810026181481 | K190336 | 000 |
| 00810026181474 | K190336 | 000 |
| 00810026181467 | K190336 | 000 |
| 00810026181450 | K190336 | 000 |
| 00810026181443 | K190336 | 000 |
| 00810026181436 | K190336 | 000 |
| 00810026181429 | K190336 | 000 |
| 00810026181412 | K190336 | 000 |
| 00810026181405 | K190336 | 000 |
| 00810026181399 | K190336 | 000 |
| 00810026181382 | K190336 | 000 |
| 00810026181375 | K190336 | 000 |
| 00810026181337 | K190336 | 000 |
| 00810026181511 | K190336 | 000 |