The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for The Versajet Ii Hydrosurgery System.
| Device ID | K143115 |
| 510k Number | K143115 |
| Device Name: | The VersaJet II Hydrosurgery System |
| Classification | Lavage, Jet |
| Applicant | SMITH & NEPHEW, INC. 970 LAKE CARILLON DRIVE SUITE 110 St. Petersburg, FL 33716 |
| Contact | Laura Reynolds |
| Correspondent | Laura Reynolds SMITH & NEPHEW, INC. 970 LAKE CARILLON DRIVE SUITE110 St. Petersburg, FL 33716 |
| Product Code | FQH |
| CFR Regulation Number | 880.5475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-30 |
| Decision Date | 2015-07-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00040565125473 | K143115 | 000 |
| 30040565124682 | K143115 | 000 |
| 30040565124699 | K143115 | 000 |
| 30040565124767 | K143115 | 000 |
| 30040565124774 | K143115 | 000 |
| 30040565124781 | K143115 | 000 |
| 00040565125497 | K143115 | 000 |
| 00040565125978 | K143115 | 000 |
| 00040565125503 | K143115 | 000 |
| 00040565124759 | K143115 | 000 |
| 30040565124675 | K143115 | 000 |