ROTH NET RETRIEVER— 510(k) K122462
Substantially EquivalentUnited States Endoscopy Group, Inc.
FDA 510(k) clearance K122462 for ROTH NET RETRIEVER, Substantially Equivalent on 2012-09-11. Applicant: United States Endoscopy Group, Inc.. Device class: 2.
Clearance details
- Applicant
- United States Endoscopy Group, Inc.
- Product code
- Code FDI
- Device class
- Class 2
- Regulation
- 21 CFR 876.4300
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mentor, OH, US
Recent devices under product code FDI
view allMore clearances from United States Endoscopy Group, Inc.
view allAdverse events under product code FDI
product code FDI- Death
- 6
- Injury
- 217
- Malfunction
- 1,544
- Total
- 1,767
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 →
Recalls naming K122462
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K122462.
Data sourced from openFDA. This site is unofficial and independent of the FDA.