FDA applicant
Unimicro Medical Systems (Shenzhen) Co., Ltd.
FDA records 5 decisions for Unimicro Medical Systems (Shenzhen) Co., Ltd. (Shenzhen, Guangdong, CN) from 2014 to 2015: 5 510(k) clearances. Most are in product codes GCJ (Laparoscope, General & Plastic Surgery) and HIF (Insufflator, Laparoscopic). Its devices cite 5 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 Unimicro Medical Systems (Shenzhen) Co., Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
3in 2015
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2014.
Planning a device like Unimicro Medical Systems (Shenzhen)…’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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