The following data is part of a premarket notification filed by Integra Radionics, Inc. with the FDA for Cusa Selector Nxt Ultrasonic Tissue Ablation System.
| Device ID | K081459 |
| 510k Number | K081459 |
| Device Name: | CUSA SELECTOR NXT ULTRASONIC TISSUE ABLATION SYSTEM |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | INTEGRA RADIONICS, INC. 22 TERRY AVENUE Burlington, MA 01803 |
| Contact | Kevin J O'connell |
| Correspondent | Kevin J O'connell INTEGRA RADIONICS, INC. 22 TERRY AVENUE Burlington, MA 01803 |
| 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 | 2008-05-23 |
| Decision Date | 2008-08-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30381780040297 | K081459 | 000 |
| M273NXT800021 | K081459 | 000 |
| M273NXT800031 | K081459 | 000 |
| 10381780121954 | K081459 | 000 |
| 10381780121961 | K081459 | 000 |
| 10381780121985 | K081459 | 000 |
| 30381780025539 | K081459 | 000 |
| 30381780040242 | K081459 | 000 |
| 10381780121992 | K081459 | 000 |
| 30381780122009 | K081459 | 000 |
| M273CUSANXT1 | K081459 | 000 |
| M273CUSANXT11 | K081459 | 000 |
| M273CUSANXT21 | K081459 | 000 |
| M273NXT100011 | K081459 | 000 |
| 10381780039525 | K081459 | 000 |
| 30381780177672 | K081459 | 000 |
| 30381780040259 | K081459 | 000 |
| M273NXT800011 | K081459 | 000 |