The following data is part of a premarket notification filed by Axya Medical, Inc. with the FDA for Axya Medical, Inc, Model 100 Sonic Scalpel Ultrasonic Surgical System.
| Device ID | K021929 |
| 510k Number | K021929 |
| Device Name: | AXYA MEDICAL, INC, MODEL 100 SONIC SCALPEL ULTRASONIC SURGICAL SYSTEM |
| Classification | Instrument, Ultrasonic Surgical |
| Applicant | AXYA MEDICAL, INC. 100 CUMMINGS CENTER SUITE 444C Beverly, MA 01915 |
| Contact | Howard L Schrayer |
| Correspondent | Howard L Schrayer AXYA MEDICAL, INC. 100 CUMMINGS CENTER SUITE 444C Beverly, MA 01915 |
| 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 | 2002-06-12 |
| Decision Date | 2002-09-10 |
| Summary: | summary |