Magic3 Go Intermittent Urinary Catheter— 510(k) K172247
Substantially EquivalentC.R. Bard, Inc.
FDA 510(k) clearance K172247 for Magic3 Go Intermittent Urinary Catheter, Substantially Equivalent on 2017-09-20. Applicant: C.R. Bard, Inc.. Device class: 2.
Clearance details
- Applicant
- C.R. Bard, 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
- Covington, GA, US
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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 →
Recalls naming K172247
K-number listed on FDA's recall record- Z-1699-2023 — Magic3 Go Intermittent Urinary Catheters, male Catalog Numbers: a) REF 50810G, b) REF 50812G, c) REF 50814G, d) REF 50816G, e) REF 50818G, f) REF 53810G, g) REF 53812G, h) REF 53814G, i) REF 53816G, j) REF 53818G, k) REF 53820G
- Z-1700-2023 — Magic3 Go Intermittent Urinary Catheters, pediatric Catalog Numbers: a) REF 52810G
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K172247.
Data sourced from openFDA. This site is unofficial and independent of the FDA.