The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Reprocessed Covidien Ligasure 5mm, Blunt Tip, Laparoscopic Sealer/divider.
| Device ID | K143260 |
| 510k Number | K143260 |
| Device Name: | Reprocessed Covidien LigaSure 5mm, Blunt Tip, Laparoscopic Sealer/Divider |
| Classification | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed |
| Applicant | STERILMED, INC. 11400 73rd Ave N Maple Grove, MN 55369 |
| Contact | Nicole Boser |
| Correspondent | Sew-wah Tay LIBRA MEDICAL 8401 73RD AVE NORTH, SUITE 63 Brooklyn Park, MN 55428 |
| Product Code | NUJ |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-13 |
| Decision Date | 2015-02-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888551007986 | K143260 | 000 |