Reach Surgical, Inc.
Registered establishment in Tianjin, China. 1 device type, 3 clearances.
Reach Surgical, Inc. is a manufacturer holding a current FDA establishment registration. The registration covers Staple, Implantable. Its earliest product listing with the FDA dates from 2016.
1device type
3510(k) clearances
Registration
| Registered name | REACH SURGICAL, INC. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3010913847 |
| FEI number | 3010913847 |
| Establishment type | Manufacturer |
Location
| City | Tianjin |
|---|---|
| Province | Tianjin |
| Address | 120 Xinxing Road |
| Postal code | 300462 |
| Country | China |
What It Makes
| Device type | Class | Listed since | Chinese makers |
|---|---|---|---|
| Staple, Implantable | Class 2 | 2016 | 16 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K192566 | 2019-10-17 | GDW | Special | This company |
| K120179 | 2012-05-23 | GDW | Traditional | This company |
| K071023 | 2008-08-28 | GDW | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2005 |
|---|---|
| Factory area | 21,000m² |
| Main products | Automatic suture units, Endoscopic staplers, Surgical energy products, Open series staplers |
| Export markets | 30+ 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.
The manufacturer named here can complete this record.