FDA applicant
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
FDA records 7 decisions for Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. (Cixi, CN) from 2019 to 2024: 7 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and OAB (Low Energy Direct Current Thermal Ablation…). Since 2016 its 510(k)s took a median of 257 days from receipt to decision, against 140 for FDA’s reviews in the same codes and years. Its devices cite 8 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 Surgnova Healthcare Technologies (Zhejiang) 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 2019.
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