FDA applicant
Saeshin Precision Co., Ltd.
FDA records 18 decisions for Saeshin Precision Co., Ltd. (Daegu, KR) from 2009 to 2026: 18 510(k) clearances. Most are in product codes EGS (Handpiece, Contra- And Right-Angle Attachment…) and EBW (Controller, Foot, Handpiece And Cord). Since 2016 its 510(k)s took a median of 288 days from receipt to decision, against 276 for FDA’s reviews in the same codes and years. Its devices cite 24 predicates, 12 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 Saeshin Precision Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2009.
Planning a device like Saeshin Precision 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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