CATHETER, SILICONE FOLEY (BARDEX)— 510(k) K760093
Substantially EquivalentC.R. Bard, Inc.
FDA 510(k) clearance K760093 for CATHETER, SILICONE FOLEY (BARDEX), Substantially Equivalent on 1976-08-23. Applicant: C.R. Bard, Inc.. Device class: 2.
Clearance details
- Applicant
- C.R. Bard, Inc.
- Product code
- Code GBM
- Device class
- Class 2
- Regulation
- 21 CFR 876.5130
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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Adverse events under product code GBM
product code GBM- Injury
- 397
- Malfunction
- 1,404
- Total
- 1,801
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 K760093
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K760093.
Data sourced from openFDA. This site is unofficial and independent of the FDA.