Fengh Medical Co., Ltd.
Registered establishment in Jiangyin, Jiangsu, China. 4 device types, 4 clearances.
Fengh Medical Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Staple, Implantable, Applier, Surgical, Clip and 2 other device types. Its earliest product listing with the FDA dates from 2019.
4device types registered with the FDA
4510(k) clearances
Registration
| Registered name | FENGH MEDICAL CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3011052945 |
| FEI number | 3011052945 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 江苏风和医疗器材股份有限公司 |
|---|---|
| Unified social credit code | 91320281583765063L |
| Source | NMPA UDI database |
Location
| City | Jiangyin |
|---|---|
| Province | Jiangsu |
| Address | NO.9 Xinsheng Road |
| Postal code | 214429 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Applier, Surgical, Clip | Class 1 | Reusable Clip Applier FRC27*9-ML, Reusable Clip Appliers FRD-L, Reusable Clip Applier FRC27*9-L, Reusable Clip Appliers FRD-XL, Reusable Clip Appliers FRC20*9-ML, Reusable Clip Applier FRC27*70-ML and 15 more | 2024 | 9 |
| Instrument, Clip Removal | Class 1 | Reusable Clip Removers HRK-LXL, Reusable Clip Removers HRQ-MLL, Reusable Clip Removers HRK-MML, Reusable Clip Removers HRQ-MML, Reusable Clip Removers HRQ-LXL, Reusable Clip Removers HRK-MLL | 2024 | 5 |
| Laparoscope, General & Plastic Surgery | Class 2 | Disposable Endoscopic Trocar | 2019 | 46 |
| Staple, Implantable | Class 2 | Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads, Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm series), Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (60mm series), Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (45mm series) | 2019 | 16 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K242679 | 2024-10-04 | GDW | Special | This company |
| K202467 | 2020-12-14 | GDW | Special | This company |
| K182476 | 2019-12-18 | GDW | Traditional | This company |
| K180208 | 2018-04-09 | GCJ | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2011 |
|---|---|
| Main products | Endoscopic linear staplers, Ligating clips, Minimally invasive surgical instruments |
| Certifications | 442 patents including 264 invention patents, ISO13485 |
| Export markets | 90+ countries |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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