The following data is part of a premarket notification filed by Us Endoscopy with the FDA for Reusable Monopolar Active Cord.
| Device ID | K192518 |
| 510k Number | K192518 |
| Device Name: | Reusable Monopolar Active Cord |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | US Endoscopy 5976 Heisley Road Mentor, OH 44060 |
| Contact | Gregory Land |
| Correspondent | Gregory Land US Endoscopy 5976 Heisley Road Mentor, OH 44060 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-13 |
| Decision Date | 2019-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00724995185213 | K192518 | 000 |