The following data is part of a premarket notification filed by Applied Urology, Inc. with the FDA for Acucise Ureteral Cutting Catheter.
| Device ID | K921838 |
| 510k Number | K921838 |
| Device Name: | ACUCISE URETERAL CUTTING CATHETER |
| Classification | Catheter, Ureteral, Gastro-urology |
| Applicant | APPLIED UROLOGY, INC. 26051 MERIT CIRCLE, BLDG. 104 Laguna Hills, CA 92653 |
| Contact | Jo Stegwell |
| Correspondent | Jo Stegwell APPLIED UROLOGY, INC. 26051 MERIT CIRCLE, BLDG. 104 Laguna Hills, CA 92653 |
| Product Code | EYB |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-17 |
| Decision Date | 1993-02-26 |