The following data is part of a premarket notification filed by Mectron Spa with the FDA for Piezosurgery Plus.
| Device ID | K153743 |
| 510k Number | K153743 |
| Device Name: | PIEZOSURGERY PLUS |
| Classification | Instrument, Surgical, Sonic And Accessory/attachment |
| Applicant | MECTRON SPA VIA LORETO 15 Corasco, IT 16042 |
| Contact | Zunino Franco |
| Correspondent | Roger Gray DONAWA LIFESCIENCE CONSULTING Srl PIAZZA ALBANIA 10 Rome, IT 00153 |
| Product Code | JDX |
| Subsequent Product Code | DZI |
| Subsequent Product Code | ERL |
| Subsequent Product Code | HBE |
| Subsequent Product Code | HWE |
| CFR Regulation Number | 888.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-28 |
| Decision Date | 2016-05-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E322036000210 | K153743 | 000 |
| E322036000050 | K153743 | 000 |
| E322036000060 | K153743 | 000 |
| E322036000070 | K153743 | 000 |
| E322036000080 | K153743 | 000 |
| E322036000090 | K153743 | 000 |
| E322036000100 | K153743 | 000 |
| E322036000110 | K153743 | 000 |
| E322036000120 | K153743 | 000 |
| E322036000130 | K153743 | 000 |
| E322036000040 | K153743 | 000 |
| E322036000030 | K153743 | 000 |
| E322036000020 | K153743 | 000 |
| E322031202430010 | K153743 | 000 |
| E322036000200 | K153743 | 000 |
| E322036300070 | K153743 | 000 |
| E322029000800010 | K153743 | 000 |
| E322029001150010 | K153743 | 000 |
| E322029001160010 | K153743 | 000 |
| E322031201270010 | K153743 | 000 |
| E322031202190010 | K153743 | 000 |
| E322036000010 | K153743 | 000 |
| E322036000140 | K153743 | 000 |
| E322036000150 | K153743 | 000 |
| E322036300010 | K153743 | 000 |
| E322036300020 | K153743 | 000 |
| E322036300030 | K153743 | 000 |
| E322036300040 | K153743 | 000 |
| E322036300050 | K153743 | 000 |
| E322036300060 | K153743 | 000 |
| E322040001020 | K153743 | 000 |
| E322051700030020 | K153743 | 000 |
| E322036000170 | K153743 | 000 |
| E322036200100 | K153743 | 000 |
| E322036200080 | K153743 | 000 |
| E322036200070 | K153743 | 000 |
| E322036100010 | K153743 | 000 |
| E322036100020 | K153743 | 000 |
| E322036100030 | K153743 | 000 |
| E322036100070 | K153743 | 000 |
| E322036100080 | K153743 | 000 |
| E322036100090 | K153743 | 000 |
| E322036200040 | K153743 | 000 |
| E322036200050 | K153743 | 000 |
| E322036200060 | K153743 | 000 |
| E322036000180 | K153743 | 000 |