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)— 510(k) K251468

Substantially Equivalent

Hollister Incorporated

FDA 510(k) clearance K251468 for 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), Substantially Equivalent on 2025-10-03. Applicant: Hollister Incorporated.

Clearance details

Applicant: Hollister Incorporated
Product code: Code EZD
Advisory panel: Gastroenterology, Urology
Date received: 2025-05-13
Decision date: 2025-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Libertyville, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code EZD

product code EZD

Injury: 864
Malfunction: 2,210
Total: 3,074

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.