The following data is part of a premarket notification filed by Halyard Health with the FDA for On-q* Echospark Echogenic Catheter; On-q* T-bloc* Echogenic Continuous Nerve Block Kit.
| Device ID | K161232 |
| 510k Number | K161232 |
| Device Name: | ON-Q* EchoSpark Echogenic Catheter; ON-Q* T-bloc* Echogenic Continuous Nerve Block Kit |
| Classification | Catheter, Conduction, Anesthetic |
| Applicant | HALYARD HEALTH 5405 WINDWARD PARKWAY Alpharetta, GA 30004 |
| Contact | Gwendolyn George |
| Correspondent | Gwendolyn George HALYARD HEALTH 5405 WINDWARD PARKWAY Alpharetta, GA 30004 |
| Product Code | BSO |
| CFR Regulation Number | 868.5120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-02 |
| Decision Date | 2016-09-30 |