Sleeved IC 2 Family +4 more— 510(k) K233524
Substantially EquivalentHollister Incorporated
FDA 510(k) clearance K233524 for Sleeved IC 2 Family +4 more, Substantially Equivalent on 2024-05-03. Applicant: Hollister Incorporated. Device class: 2.
Clearance details
- Device name as filed
- 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)
- Applicant
- Hollister Incorporated
- Product code
- 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)
- K220667 — Sleeved IC
- K213575 — Female IC (Not Finalized)
- K211436 — Intermittent Catheter (Not Finalized)
- K193148 — VaPro Plus Pocket, VaPro Plus
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.