FDA applicant
Tentech Co., Ltd.
FDA records 2 decisions for Tentech Co., Ltd. (Gangnam-Gu, KR) from 2022 to 2023: 2 510(k) clearances. Most are in product codes ONF (Powered Light Based Non-Laser Surgical…) and GEI (Electrosurgical, Cutting & Coagulation &…). Its devices cite 4 predicates, 0 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Tentech, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Tentech Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2022.
Planning a device like Tentech 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