The following data is part of a premarket notification filed by Xodus Medical, Inc. with the FDA for Cautery Tip Cleaner, Model 30500.
| Device ID | K053433 |
| 510k Number | K053433 |
| Device Name: | CAUTERY TIP CLEANER, MODEL 30500 |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | XODUS MEDICAL, INC. 702 PROMINENCE DR. New Kensington, PA 15068 |
| Contact | Brenda Niel |
| Correspondent | Brenda Niel XODUS MEDICAL, INC. 702 PROMINENCE DR. New Kensington, PA 15068 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-09 |
| Decision Date | 2006-01-19 |
| Summary: | summary |