The following data is part of a premarket notification filed by Integra Lifesciences Corporation with the FDA for Cusa Clarity Ultrasonic Surgical Aspirator System.
| Device ID | K161882 |
| 510k Number | K161882 |
| Device Name: | CUSA Clarity Ultrasonic Surgical Aspirator System |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DRIVE Plainsboro, NJ 08536 |
| Contact | Resham Ramsay |
| Correspondent | Resham Ramsay INTEGRA LIFESCIENCES CORPORATION 311 ENTERPRISE DRIVE Plainsboro, NJ 08536 |
| 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 | 2016-07-11 |
| Decision Date | 2016-10-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780357483 | K161882 | 000 |
| 30381780126373 | K161882 | 000 |
| 30381780126366 | K161882 | 000 |
| 30381780126359 | K161882 | 000 |
| 10381780126324 | K161882 | 000 |
| 10381780126317 | K161882 | 000 |
| 30381780126304 | K161882 | 000 |
| 10381780126294 | K161882 | 000 |
| 30381780126281 | K161882 | 000 |
| 10381780126423 | K161882 | 000 |
| 30381780126380 | K161882 | 000 |
| 10381780126409 | K161882 | 000 |
| 10381780126461 | K161882 | 000 |
| 10381780126263 | K161882 | 000 |
| 10381780126256 | K161882 | 000 |
| 10381780251316 | K161882 | 000 |
| 30381780251303 | K161882 | 000 |
| 10381780126478 | K161882 | 000 |
| 10381780126454 | K161882 | 000 |
| 10381780126447 | K161882 | 000 |
| 10381780126430 | K161882 | 000 |
| 10381780126416 | K161882 | 000 |