FDA 510(k) K220411, Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A), by Stryker Sustainability Solutions
FDA 510(k) K220411, Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A), by Stryker Sustainability Solutions
| 510(k) Number | K220411 |
| Device Classification Name | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed |
| Device Name | Reprocessed LigaSure Curved, Small Jaw, Open Sealer/Divider (LF1212A) |
| Applicant | Stryker Sustainability Solutions 1810 W Dr.Ake Dr. Tempe, AZ 85283 |
| Regulation Number | 878.44 |
| Classification Product Code | NUJ |
| Date Received | 02/14/2022 |
| Decision Date | 05/13/2022 |
| Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | General & Plastic Surgery |
| 510k Review Panel | General & Plastic Surgery |
| Type | Traditional |
| Reviewed by Third Party | No |
| Combination Product | No |
| Total Pages | 4332 |
| Redacted Pages | 4111 |
| Unredacted Pages | 221 |
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