FDA applicant
Suzhou Endophix Co., Ltd.
FDA records 4 decisions for Suzhou Endophix Co., Ltd. (Suzhou, CN) from 2023 to 2024: 4 510(k) clearances. All are in product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue). Since 2016 its 510(k)s took a median of 59 days from receipt to decision, against 57 for FDA’s reviews in the same codes and years. Its devices cite 19 predicates, 0 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 Suzhou Endophix Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2023.
Planning a device like Suzhou Endophix 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