K211436 is an FDA 510(k) clearance for the Intermittent Catheter (Not Finalized). This device is classified as a Catheter, Urethral (Class II - Special Controls, product code GBM).
Submitted by Hollister Incorporated (Libertyville, US). The FDA issued a Cleared decision on January 27, 2022, 262 days after receiving the submission on May 10, 2021.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K211436 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 10, 2021 |
| Decision Date | January 27, 2022 |
| Days to Decision | 262 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | GBM — Catheter, Urethral |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |