The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Peel-away Introducer.
| Device ID | K182403 |
| 510k Number | K182403 |
| Device Name: | Peel-Away Introducer |
| Classification | Endoscopic Access Overtube, Gastroenterology-urology |
| Applicant | Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Contact | Johnathan Liu |
| Correspondent | Johnathan Liu Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Product Code | FED |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-04 |
| Decision Date | 2019-05-29 |