510(k) K260997 ยท PLL Submucosal Injection Agent
SIS BLU (SISBLU-30-01);SIS BLU (SISBLU-15-01)
| Applicant | Endoclot Plus Co., Ltd., Suzhou, CN |
| Decision | Substantially Equivalent, Sep 9, 2026 |
| Received | Mar 26, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260997
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.