The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Ncompass Nitinol Stone Extractors.
| Device ID | K173009 |
| 510k Number | K173009 |
| Device Name: | NCompass Nitinol Stone Extractors |
| Classification | Dislodger, Stone, Biliary |
| Applicant | Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402 |
| Contact | Colin Jacob |
| Correspondent | Colin Jacob Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402 |
| Product Code | LQR |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-27 |
| Decision Date | 2017-11-07 |
| Summary: | summary |