The following data is part of a premarket notification filed by Xodus Medical, Inc. with the FDA for Electrosurgical Pencil With Ptfe Coated & Uncoated Electrode Tips.
| Device ID | K081647 |
| 510k Number | K081647 |
| Device Name: | ELECTROSURGICAL PENCIL WITH PTFE COATED & UNCOATED ELECTRODE TIPS |
| 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 | 2008-06-12 |
| Decision Date | 2008-08-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20787551035111 | K081647 | 000 |