The following data is part of a premarket notification filed by Endo Optiks, Inc. with the FDA for Endo Optiks Urological Catheter For Endoscopy, Model Sessr.
| Device ID | K083788 |
| 510k Number | K083788 |
| Device Name: | ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSR |
| Classification | Catheter, Ureteral, Gastro-urology |
| Applicant | ENDO OPTIKS, INC. 39 SYCAMORE AVE. Little Silver, NJ 07739 -1208 |
| Contact | Donald R Watson |
| Correspondent | Donald R Watson ENDO OPTIKS, INC. 39 SYCAMORE AVE. Little Silver, NJ 07739 -1208 |
| Product Code | EYB |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-19 |
| Decision Date | 2009-03-03 |
| Summary: | summary |