The following data is part of a premarket notification filed by Us Medical Innovations, Llc with the FDA for Canady Plasma Smart Xl-1000 Electrosurgical Generator With Accessories.
| Device ID | K192124 |
| 501k Number | K192124 |
| Device Name: | Canady Plasma SMART XL-1000 Electrosurgical Generator With Accessories |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | US Medical Innovations, LLC 6930 Carroll Ave Takoma Park, MD 20912 |
| Contact | David Hinds |
| Correspondent | Tim Joiner Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | General & Plastic Surgery |
| 501k Review Panel | General & Plastic Surgery |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-06 |
| Decision Date | 2019-11-21 |