Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares— 510(k) K202478
Substantially EquivalentBoston Scientific Corporation
FDA 510(k) clearance K202478 for Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares, Substantially Equivalent on 2020-10-08. Applicant: Boston Scientific Corporation. Device class: 2.
Clearance details
- Applicant
- Boston Scientific Corporation
- Product code
- Code FDI
- Device class
- Class 2
- Regulation
- 21 CFR 876.4300
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Marlboro, MA, US
Recent devices under product code FDI
view allMore clearances from Boston Scientific Corporation
view allAdverse events under product code FDI
product code FDI- Death
- 6
- Injury
- 217
- Malfunction
- 1,544
- Total
- 1,767
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 K202478
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 K202478.
Data sourced from openFDA. This site is unofficial and independent of the FDA.