HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE— 510(k) K013066
Substantially EquivalentOlympus America, Inc.
FDA 510(k) clearance K013066 for HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE, Substantially Equivalent on 2001-12-11. Applicant: Olympus America, Inc.. Device class: 2.
Clearance details
- Applicant
- Olympus America, Inc.
- Product code
- Code MND
- Device class
- Class 2
- Regulation
- 21 CFR 876.4400
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Melville, NY, US
Recent devices under product code MND
view allMore clearances from Olympus America, Inc.
view allAdverse events under product code MND
product code MND- Death
- 6
- Injury
- 255
- Malfunction
- 4,495
- Total
- 4,756
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 K013066
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 K013066.
Data sourced from openFDA. This site is unofficial and independent of the FDA.