K212077 is an FDA 510(k) clearance for the Teleflex Rusch SoftSimplastic Foley Catheters. This device is classified as a Catheter, Retention Type, Balloon (Class II - Special Controls, product code EZL).
Submitted by Teleflexmedical, Inc. (Morrisville, US). The FDA issued a Cleared decision on July 27, 2023, 755 days after receiving the submission on July 2, 2021.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K212077 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 2021 |
| Decision Date | July 27, 2023 |
| Days to Decision | 755 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | EZL — Catheter, Retention Type, Balloon |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |