510(k) K171454 ยท FBK Endoscopic Injection Needle, Gastroenterology-Urology
Interject Injection Therapy Needle Catheter
| Applicant | Boston Scientific Corporation, Marlboro MA, US |
| Decision | Substantially Equivalent, Jul 7, 2017 |
| Received | May 17, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171454
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 11, 2022 | Boston Scientific Corporation ORISE Gel Syringe Submucosal Lifting Agent Kits: indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal muco Open, Classified |
FBK | None listed |
| Nov 11, 2022 | Boston Scientific Corporation ORISE ProKnife Procedure Kits: indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prio Open, Classified |
FBK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.