The following data is part of a premarket notification filed by Cook Incorporated with the FDA for One-step Suprapubic Introducer.
| Device ID | K182709 |
| 510k Number | K182709 |
| Device Name: | One-Step Suprapubic Introducer |
| Classification | Catheter, Suprapubic (and Accessories) |
| Applicant | Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Contact | Carly Powell |
| Correspondent | Carly Powell Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Product Code | KOB |
| CFR Regulation Number | 876.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-27 |
| Decision Date | 2018-12-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002266667 | K182709 | 000 |
| 00827002266551 | K182709 | 000 |
| 00827002266483 | K182709 | 000 |
| 00827002266421 | K182709 | 000 |
| 00827002259812 | K182709 | 000 |