The following data is part of a premarket notification filed by Stryker Sustainability Solutions with the FDA for Reprocessed Ligasure Blunt Tip Laparoscopic Sealer/divider.
| Device ID | K133578 |
| 510k Number | K133578 |
| Device Name: | REPROCESSED LIGASURE BLUNT TIP LAPAROSCOPIC SEALER/DIVIDER |
| Classification | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed |
| Applicant | STRYKER SUSTAINABILITY SOLUTIONS 1810 WEST DRAKE DRIVE Tempe, AZ 85283 |
| Contact | Jill Clark |
| Correspondent | Jill Clark STRYKER SUSTAINABILITY SOLUTIONS 1810 WEST 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 | 2013-11-21 |
| Decision Date | 2014-04-10 |
| Summary: | summary |