EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS, EXTRACTOR PRO DL RETRIEVAL BALLONS MODEL M005470— 510(k) K102082
Substantially EquivalentBoston Scientific Corp
FDA 510(k) clearance K102082 for EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS, EXTRACTOR PRO DL RETRIEVAL BALLONS MODEL M005470, Substantially Equivalent on 2010-08-23. Applicant: Boston Scientific Corp.
Clearance details
- Applicant
- Boston Scientific Corp
- Product code
- Code FGE
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Marlboro, MA, US
Adverse events under product code FGE
product code FGE- Death
- 52
- Injury
- 2,347
- Malfunction
- 9,798
- Other
- 1
- Total
- 12,198
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.