FOCUS (TM) ECHOGENIC NERVE STIMULATING NEEDLE— 510(k) K101728
Substantially EquivalentCook, Inc.
FDA 510(k) clearance K101728 for FOCUS (TM) ECHOGENIC NERVE STIMULATING NEEDLE, Substantially Equivalent on 2010-08-25. Applicant: Cook, Inc.. Device class: 2.
Clearance details
- Applicant
- Cook, Inc.
- 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
- Special
- Location
- Bloomington, IN, 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.