MONOJECT PLASTIC HUB SPINAL NEEDLE— 510(k) K822630
Substantially EquivalentSherwood Medical Co.
FDA 510(k) clearance K822630 for MONOJECT PLASTIC HUB SPINAL NEEDLE, Substantially Equivalent on 1982-10-04. Applicant: Sherwood Medical Co.. Device class: 2.
Clearance details
- Applicant
- Sherwood Medical Co.
- 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
- Mchenry, IL, 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.