510(k) DEN220006
- Device
- ProdiGI
- Applicant
- Covidien, LLC
- 510(k) number
- DEN220006
- Product code
- QSW
- Decision
- Unknown (DENG)
- Decision date
- 2022-06-13
- Date received
- 2022-01-14
- Regulation
- 876.4410
- Classification name
- Endoscopic Traction Device
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Liron Bar Yaakov
- Address
- 3062 Bunkerhill Ln. Santa Clara CA US 95054 95054
FDA Registration Numbers#
- 3013440400
- 3004904811
- 3018094310
- 3004837686
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code QSW#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K222354 | Elastic Traction System | Micro-Tech (Nanjing) Co., Ltd. | 2022-10-03 |