FDA applicant
Endoclot Plus Co., Ltd.
FDA records 4 decisions for Endoclot Plus Co., Ltd. (Suzhou, CN) from 2017 to 2026: 4 510(k) clearances. Most are in product codes PLL (Submucosal Injection Agent) and QAU (Hemostatic Device For Endoscopic…). Its devices cite 7 predicates, 2 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Endoclot Plus Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2021
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2017.
Planning a device like Endoclot Plus Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report