USCI ENDOPROSTHESIS— 510(k) K834574
Substantially EquivalentC.R. Bard, Inc.
FDA 510(k) clearance K834574 for USCI ENDOPROSTHESIS, Substantially Equivalent on 1984-04-05. Applicant: C.R. Bard, Inc.. Device class: 2.
Clearance details
- Applicant
- C.R. Bard, Inc.
- Product code
- Code FGE
- Device class
- Class 2
- Regulation
- 21 CFR 876.5010
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code FGE
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- K253832 — Dilation Balloon Catheter
- K251658 — Endoflux Biliary & Pancreatic Stent Sets
- K253987 — BARE Wireguided Balloon Dilation Catheter (1235)
More clearances from C.R. Bard, Inc.
view all- K253514 — Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220) +2 more
- K254076 — BD Touchless Plus Unisex Pre-Lubricated Urethral Catheter Kit
- K252971 — Elyra Thulium Fiber Laser System and Elyra Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)
- K251864 — Rubber Utility Catheter
- K251186 — Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)
Adverse events under product code FGE
product code FGE- Death
- 52
- Injury
- 2,347
- Malfunction
- 9,798
- Other
- 1
- Total
- 12,198
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.