The following data is part of a premarket notification filed by Stryker Sustainability Solutions with the FDA for Reprocessed Ligasure Impacttm Curved, Large Jaw, Open Sealer/divider.
| Device ID | K150538 |
| 510k Number | K150538 |
| Device Name: | Reprocessed LigaSure ImpactTM Curved, Large Jaw, Open Sealer/Divider |
| Classification | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed |
| 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 | NUJ |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-03 |
| Decision Date | 2015-06-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50885825017885 | K150538 | 000 |