Instrument, Ultrasonic Surgical
Which Manufacturers in China Make This?
Chinese manufacturers registered for this device type are concentrated in Beijing, Zhejiang and Chongqing, and 2 other provinces: 7 hold an FDA registration.
- Agibot Medtech (Suzhou) Co., Ltd. Jiangsu
- Huaan Hengyi (Beijing) Medical Technology Co., Ltd. Beijing, contract manufacturer
- Hunan Handlike Minimally Invasive Surgery Co., Ltd. Hunan
- Miconvey Technologies Co., Ltd. Chongqing
- Ningbo Huakun Medical Equipment Co., Ltd. Zhejiang, contract manufacturer
- Smtp Medical Co., Ltd. Beijing
- Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. Zhejiang
How Is LFL Classified?
Instrument, Ultrasonic Surgical is FDA product code LFL, unclassified.
How Does It Reach the US Market?
A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. Chinese applicants hold 6 clearances under this code; the FDA took a median of 274 days from receipt to decision on them. One went the Special 510(k) route, the one for a change to the applicant’s own cleared device.
What Do the Recalls Say?
The FDA has recorded 109 recalls under this product code since 2003. None was by a company in China. The root causes the FDA records most often are Device Design (49), Nonconforming Material/Component (14) and Process control (3).
A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.