FDA applicant
Scivita Medical Technology Co., Ltd.
FDA records 13 decisions for Scivita Medical Technology Co., Ltd. (Suzhou, CN) from 2019 to 2026: 13 510(k) clearances. Most are in product codes EOQ (Bronchoscope (Flexible Or Rigid)) and GCJ (Laparoscope, General & Plastic Surgery). Since 2016 its 510(k)s took a median of 172 days from receipt to decision, against 134 for FDA’s reviews in the same codes and years. Its devices cite 14 predicates, 5 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 Scivita Medical Technology Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2019.
Planning a device like Scivita Medical Technology Co., Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
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