510(k) K102082 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS, EXTRACTOR PRO DL RETRIEVAL BALLONS MODEL M005470
| Applicant | Boston Scientific Corp, Marlboro MA, US |
| Decision | Substantially Equivalent, Aug 23, 2010 |
| Received | Jul 26, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K102082
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 23, 2025 | Boston Scientific Corporation Extractor Pro RX Retrieval Balloon Catheter;
UPN (REF): (1) M00547030 (9-12mm Below), (2) M00547000 (9-12mm Above); Open, Classified |
FGE | None listed |
| Jul 1, 2015 | Boston Scientific Corporation Extractor Pro RX Retrieval Balloon Catheter 9-12 mm Above Retrieval Balloon Catheter; Universal Product Number (UPN) M00547000
The Extractor Pro RX Retrieval Balloon Catheters are intended for use end Terminated |
FGE | None listed |
| Jan 10, 2014 | Boston Scientific Corporation Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 9-12 mm Injects Above
UPN: M00547100
The Extractor Pro XL Retrieval Balloon Catheter is used endoscopically to 1) remove stones from the b Terminated |
FGE | None listed |
| Jan 10, 2014 | Boston Scientific Corporation Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm Injects Above
UPN: M00547110 Terminated |
FGE | None listed |
| Jan 10, 2014 | Boston Scientific Corporation Boston Scientific Extractor Pro XL Retrieval Balloon Catheter 12-15 mm
Injects Below
UPN :M00547140 Terminated |
None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.