Data / Medical devices / China / Fengh Medical Co., Ltd.
Fengh Medical Co., Ltd.: FDA-registered device maker in Jiangyin Jiangsu, China, 4 510(k) clearances
Fengh Medical Co., Ltd. is registered with the FDA (registration 3011052945) in Jiangyin Jiangsu, China. It lists 4 device types. The FDA files 4 510(k) clearances under its listings, the newest dated October 4, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3011052945
- Address
- NO.9 Xinsheng Road, Jiangyin Jiangsu, China, 214429
- Owner or operator
- Fengh Medical Co., Ltd. (10061944)
- Roles
- Manufacturer
- First device listed
- December 11, 2019
- Registered through
- 2027
- Brand names listed
- Disposable Endoscopic Trocar, 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 (45mm series), Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (60mm series), Reusable Clip Applier FRC27*70-L, Reusable Clip Applier FRC27*70-ML, Reusable Clip Applier FRC27*70-XL and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Applier, Surgical, Clip | GDO | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Clip Removal | HBQ | 1 | Manufacturer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Manufacturer | accessdata.fda.gov |
| Staple, Implantable | GDW | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 4, 2024 | K242679 | Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (30mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (45mm series); Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads (60mm series) | GDW | Substantially Equivalent | Fengh Medical Co., Ltd. | accessdata.fda.gov |
| December 14, 2020 | K202467 | Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads | GDW | Substantially Equivalent | Fengh Medical Co., Ltd. | accessdata.fda.gov |
| December 18, 2019 | K182476 | Disposable Powered Articulating Endoscopic Linear Cutter Stapler & Reloads | GDW | Substantially Equivalent | Fengh Medical Co., Ltd. | accessdata.fda.gov |
| April 9, 2018 | K180208 | Disposable Endoscopic Trocar | GCJ | Substantially Equivalent | Fengh Medical Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Staple, Implantable
- All makers of Applier, Surgical, Clip
- All makers of Instrument, Clip Removal
- All makers of Laparoscope, General & Plastic Surgery
Updated October 4, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.