510(k) K110030 ยท ODG Endoscopic Ultrasound System, Gastroenterology-Urology
EXPECT ENDOSCOPIC ASPIRATION NEEDLE
| Applicant | Boston Scientific Corp, Marlboro MA, US |
| Decision | Substantially Equivalent, Jan 12, 2011 |
| Received | Jan 5, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K110030
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 16, 2011 | Boston Scientific Corporation Boston Scientific 25ga (0.52mm) Expect Endoscopic Ultrasound Aspiration Needle REF 5002 Use By 1999-12 LOT 13615651C1 STERILE EO
The Expect Needle is designed to sample targeted submucosal and extram Terminated |
FCG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.