The following data is part of a premarket notification filed by Ximed/prosure/injectx with the FDA for Percutx-injection/aspiration Needle Probes/devices.
| Device ID | K994151 |
| 510k Number | K994151 |
| Device Name: | PERCUTX-INJECTION/ASPIRATION NEEDLE PROBES/DEVICES |
| Classification | Needle, Aspiration And Injection, Disposable |
| Applicant | XIMED/PROSURE/INJECTX 2195 TRADE ZONE BLVD. San Jose, CA 95131 |
| Contact | Lee Bui |
| Correspondent | Lee Bui XIMED/PROSURE/INJECTX 2195 TRADE ZONE BLVD. San Jose, CA 95131 |
| Product Code | GAA |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-09 |
| Decision Date | 2000-03-01 |