Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus— 510(k) K221593
Substantially EquivalentConvatec, Inc.
FDA 510(k) clearance K221593 for Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus, Substantially Equivalent on 2022-11-17. Applicant: Convatec, Inc.. Device class: 2.
Clearance details
- Applicant
- Convatec, Inc.
- 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
- Greensboro, NC, US
Recent devices under product code EZD
view allMore clearances from Convatec, Inc.
view all- K230400 — Cure Catheter Closed System; Cure Dextra Closed System
- K123481 — AQUACEL AG FOAM HYDROFIBER FOAM DRESSING WITH SILVER, ADHESIVE AND NON ADHESIVE
- K121275 — AQUACEL AG EXTRA HYDROFIBER DRESSING WITH SILVER AND STRENGTHENING FIBER
- K112342 — FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM
- K111365 — VITALA CONTINENCE CONTROL DEVICE
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.