K010637 is an FDA 510(k) clearance for the SONOTOME ULTRASONIC ASPIRATOR TIPS. This device is classified as a Instrument, Ultrasonic Surgical.
Submitted by Synergetics, Inc. (St. Charles, US). The FDA issued a Cleared decision on April 20, 2001, 46 days after receiving the submission on March 5, 2001.
This device falls under the General & Plastic Surgery FDA review panel.
| 510(k) Number | K010637 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 05, 2001 |
| Decision Date | April 20, 2001 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | LFL — Instrument, Ultrasonic Surgical |
| Device Class | — |