The following data is part of a premarket notification filed by Dextera Surgical Inc. with the FDA for Dextera Microcutter 30 Blue Reload, Dextera Microcutter 30 Curved Tip Blue Reload, Dextera Microcutter 30 White Reload, Dextera Microcutter 30 Curved Tip White Reload.
| Device ID | K171561 |
| 510k Number | K171561 |
| Device Name: | Dextera MicroCutter 30 Blue Reload, Dextera MicroCutter 30 Curved Tip Blue Reload, Dextera MicroCutter 30 White Reload, Dextera MicroCutter 30 Curved Tip White Reload |
| Classification | Staple, Implantable |
| Applicant | Dextera Surgical Inc. 900 Saginaw Drive Redwood City, CA 94063 |
| Contact | Greg Watson |
| Correspondent | Pamela Segale Dextera Surgical Inc. 900 Saginaw Drive Redwood City, CA 94063 |
| Product Code | GDW |
| CFR Regulation Number | 878.4750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-30 |
| Decision Date | 2017-08-28 |
| Summary: | summary |