PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT— 510(k) K100461
Substantially EquivalentRiverpoint Medical
FDA 510(k) clearance K100461 for PDM, VILET, VILET QUICK, MONO Q, PLAIN GUT:# 6 CHROMIC GUT, Substantially Equivalent on 2010-07-08. Applicant: Riverpoint Medical. Device class: 2.
Clearance details
- Applicant
- Riverpoint Medical
- Product code
- Code NEW
- Device class
- Class 2
- Regulation
- 21 CFR 878.4840
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Location
- Portland, OR, US
Recent devices under product code NEW
view allMore clearances from Riverpoint Medical
view allAdverse events under product code NEW
product code NEW- Death
- 32
- Injury
- 2,179
- Malfunction
- 8,975
- Total
- 11,186
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 K100461
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 K100461.
Data sourced from openFDA. This site is unofficial and independent of the FDA.