The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Electrocautery Pencil.
| Device ID | K190643 |
| 510k Number | K190643 |
| Device Name: | Medline Electrocautery Pencil |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 |
| Contact | Matt Clausen |
| Correspondent | Matt Clausen Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-03-13 |
| Decision Date | 2019-05-06 |