510(k) K100712 ยท FCG Biopsy Needle
RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE
| Applicant | Boston Scientific Corporation, Marlboro MA, US |
| Decision | Substantially Equivalent, Mar 30, 2010 |
| Received | Mar 12, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100712
| 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 |
| Dec 27, 2010 | Boston Scientific Corporation Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, Single Pack, 22GA (0.72 mm) sterile, UPN M00550010, 428
Technology Drive East, Menomonie, WI.
Designed to sample targeted submucosal Terminated |
FCG | None listed |
| Dec 27, 2010 | Boston Scientific Corporation Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, Single Pack, 25GA (0.52 mm) sterile, UPN M00550020, 428 Technology Drive East, Menomonie, WI.
Designed to sample targeted submucosa Terminated |
FCG | None listed |
| Dec 27, 2010 | Boston Scientific Corporation Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, 22GA (0.72 mm) sterile, UPN M00550011, 5 pack, 428 Technology Drive East, Menomonie, WI.
Designed to sample targeted submucosal and e Terminated |
FCG | None listed |
| Dec 27, 2010 | Boston Scientific Corporation Boston Scientific Expect Endoscopic Ultrasound Aspiration Needle, 25GA (0.52 mm) sterile, UPN M00550021, 5 pack, 428 Technology Drive East, Menomonie, WI.
Designed to sample targeted submucosal and e Terminated |
FCG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.