The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Williams Cystoscopic Injection Needle.
| Device ID | K171602 |
| 510k Number | K171602 |
| Device Name: | Williams Cystoscopic Injection Needle |
| Classification | Endoscopic Injection Needle, Gastroenterology-urology |
| Applicant | Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402 |
| Contact | Rebecca Odulio (li-chun Liu) |
| Correspondent | Rebecca Odulio (li-chun Liu) Cook Incorporated 750 Daniels Way, P.O. Box 489 Bloomington, IN 47402 |
| Product Code | FBK |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-01 |
| Decision Date | 2017-07-28 |
| Summary: | summary |