FDA applicant
Shanghai SeeGen Photoelectric Technology Co., Ltd.
FDA records 6 decisions for Shanghai SeeGen Photoelectric Technology Co., Ltd. (Shanghai, CN) from 2022 to 2026: 6 510(k) clearances. Most are in product codes FBN (Choledochoscope And Accessories, Flexible/Rigid) and FGB (Ureteroscope And Accessories, Flexible/Rigid). Since 2016 its 510(k)s took a median of 265 days from receipt to decision, against 150 for FDA’s reviews in the same codes and years. Its devices cite 5 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 Shanghai SeeGen Photoelectric Technology Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2022.
Planning a device like Shanghai SeeGen Photoelectric…’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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