The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Reprocessed Harmonic Shears With Adaptive Tissue Technology (36 Cm), Reprocessed Harmonic Shears With Adaptive Tissue Technology (23cm).
| Device ID | K161086 |
| 510k Number | K161086 |
| Device Name: | Reprocessed Harmonic Shears With Adaptive Tissue Technology (36 Cm), Reprocessed Harmonic Shears With Adaptive Tissue Technology (23cm) |
| Classification | Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed |
| Applicant | Sterilmed, Inc. 5010 Cheshire Parkway, Suite 2 Plymouth, MN 55446 |
| Contact | Patricia Kaufman |
| Correspondent | Neelu Gibson Sterilmed, Inc. 5010 Cheshire Parkway, Suite 2 Plymouth, MN 55446 |
| Product Code | NUJ |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-18 |
| Decision Date | 2016-09-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888551045117 | K161086 | 000 |
| 10888551045100 | K161086 | 000 |