STAMEY SAMPLER SPRING LOADED BIOPSY NEEDLE— 510(k) K885169
Substantially EquivalentBoston Scientific Corp
FDA 510(k) clearance K885169 for STAMEY SAMPLER SPRING LOADED BIOPSY NEEDLE, Substantially Equivalent on 1989-02-27. Applicant: Boston Scientific Corp. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Corp
- Product code
- Code KNW
- Device class
- Class 2
- Regulation
- 21 CFR 876.1075
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Watertown, MA, US
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Adverse events under product code KNW
product code KNW- Death
- 9
- Injury
- 965
- Malfunction
- 10,444
- Other
- 3
- Total
- 11,421
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.