BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle— 510(k) K211085
Substantially EquivalentBecton, Dickinson and Company
FDA 510(k) clearance K211085 for BD Perisafe Tuohy Epidural Needle, BD Perisafe Weiss Epidural Needle, Substantially Equivalent on 2022-07-01. Applicant: Becton, Dickinson and Company. Device class: 2.
Clearance details
- Applicant
- Becton, Dickinson and Company
- Product code
- Code BSP
- Device class
- Class 2
- Regulation
- 21 CFR 868.5150
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Franklin Lakes, NJ, US
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Adverse events under product code BSP
product code BSP- Death
- 2
- Total
- 2
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.