The following data is part of a premarket notification filed by Stryker Sustainability Solutions with the FDA for Remanufactured Ligasure Exact Dissector, Without Nano-coating (lf2019).
| Device ID | K220481 |
| 510k Number | K220481 |
| Device Name: | Remanufactured LigaSure Exact Dissector, Without Nano-coating (LF2019) |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Stryker Sustainability Solutions 1810 W Drake Drive Tempe, AZ 85283 |
| Contact | Scott English |
| Correspondent | Scott English Stryker Sustainability Solutions 1810 W Drake Drive Tempe, AZ 85283 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-18 |
| Decision Date | 2022-05-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 57613327565312 | K220481 | 000 |