Sterile Endoscope Biopsy Sampling Needle— 510(k) K171956
Substantially EquivalentChangzhou Detain Medical Devices Co., Ltd.
FDA 510(k) clearance K171956 for Sterile Endoscope Biopsy Sampling Needle, Substantially Equivalent on 2017-12-12. Applicant: Changzhou Detain Medical Devices Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Changzhou Detain Medical Devices Co., Ltd.
- Product code
- Code FCG
- Device class
- Class 2
- Regulation
- 21 CFR 876.1075
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Changzhou, CN
Recent devices under product code FCG
view allAdverse events under product code FCG
product code FCG- Death
- 13
- Injury
- 576
- Malfunction
- 1,966
- Total
- 2,555
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.