BARD SINGULAR BIOPSY FORCEPS— 510(k) K912214
Substantially EquivalentC.R. Bard, Inc.
FDA 510(k) clearance K912214 for BARD SINGULAR BIOPSY FORCEPS, Substantially Equivalent on 1991-05-30. Applicant: C.R. Bard, Inc.. Device class: 1.
Clearance details
- Applicant
- C.R. Bard, Inc.
- Product code
- Code FCL
- Device class
- Class 1
- Regulation
- 21 CFR 876.1075
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tewksbury, MA, US
Recent devices under product code FCL
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- K251864 — Rubber Utility Catheter
- K251186 — Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)
Adverse events under product code FCL
product code FCL- Death
- 5
- Total
- 5
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.