Coude Sleeved IC; Coude Plus Sleeved IC— 510(k) K253295
Substantially EquivalentHollister Incorporated
FDA 510(k) clearance K253295 for Coude Sleeved IC; Coude Plus Sleeved IC, Substantially Equivalent on 2026-05-18. Applicant: Hollister Incorporated. Device class: 2.
Summary
Hollister's record covers two items, Coude Sleeved IC and Coude Plus Sleeved IC, under EZD, straight catheters. The record doesn't expand "IC".
Class II, 21 CFR 876.5130. Gastroenterology and Urology is both the classification panel and the review panel. The submission was a Traditional 510(k).
Hollister filed from Libertyville, Illinois. The decision came 231 calendar days after receipt (September 29, 2025 to May 18, 2026).
Clearance details
- Applicant
- Hollister Incorporated
- Product code
- Product code EZD
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Libertyville, IL, US
Recent devices under product code EZD
view allMore clearances from Hollister Incorporated
view all- K251468 — 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)
- K233524 — Sleeved IC 2 Family +4 more
- K220667 — Sleeved IC
- K213575 — Female IC (Not Finalized)
- K211436 — Intermittent Catheter (Not Finalized)
Adverse events under product code EZD
product code EZD- Injury
- 864
- Malfunction
- 2,210
- Total
- 3,074
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.