Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized)— 510(k) K233524

Substantially Equivalent

Hollister Incorporated

FDA 510(k) clearance K233524 for Sleeved IC 2 Family; Sleeved IC 2 SWT (Name not Finalized); Sleeved IC 2 Plus (Name not Finalized); Sleeved IC 2 Pocket (Name not Finalized); Sleeved IC 2 Plus Pocket (Name not Finalized), Substantially Equivalent on 2024-05-03. Applicant: Hollister Incorporated.

Clearance details

Applicant: Hollister Incorporated
Product code: Code EZD
Advisory panel: Gastroenterology, Urology
Date received: 2023-11-01
Decision date: 2024-05-03
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.