510(k) K180068 ยท PLL Submucosal Injection Agent
ORISE Gel
| Applicant | Boston Scientific, Marlboro MA, US |
| Decision | Substantially Equivalent, Sep 28, 2018 |
| Received | Jan 9, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180068
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 11, 2022 | Boston Scientific Corporation ORISE Gel Submucosal Lifting Agent--Indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, Open, Classified |
PLL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.