K251468 is an FDA 510(k) clearance for the Sleeved IC 3 Family Sleeved IC 3 SWT (name not finalized) Sleeved IC 3 Pocket (name not finalized) Sleeved IC 3 Plus (name not finalized) Sleeved IC 3 Plus Pocket (name not finalized) (N/A). This device is classified as a Catheter, Straight (Class II - Special Controls, product code EZD).
Submitted by Hollister Incorporated (Libertyville, US). The FDA issued a Cleared decision on October 3, 2025, 143 days after receiving the submission on May 13, 2025.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K251468 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 13, 2025 |
| Decision Date | October 03, 2025 |
| Days to Decision | 143 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | EZD - Catheter, Straight |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |