FDA applicant
Hunan Endoso Life Technology Co., Ltd.
FDA records 3 decisions for Hunan Endoso Life Technology Co., Ltd. (Xiangtan, CN) from 2023 to 2025: 3 510(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 203 days from receipt to decision, against 130 for FDA’s reviews in the same codes and years. Its devices cite 3 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 Hunan Endoso Life 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 2023.
Planning a device like Hunan Endoso Life 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.
See the 510(k) Report