DORNOCH DUO SUCTION CART WITH: DL2800 LID, CL500 LID, DORNOCH QUAD SUCTION CART WITH: DL2800 LID, CL500 LID— 510(k) K133786
Substantially EquivalentDornoch Medical Systems, Inc.
FDA 510(k) clearance K133786 for DORNOCH DUO SUCTION CART WITH: DL2800 LID, CL500 LID, DORNOCH QUAD SUCTION CART WITH: DL2800 LID, CL500 LID, Substantially Equivalent on 2014-03-21. Applicant: Dornoch Medical Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Dornoch Medical Systems, Inc.
- Product code
- Code JCX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4780
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Riverside, MO, US
Recent devices under product code JCX
view allMore clearances from Dornoch Medical Systems, Inc.
view allAdverse events under product code JCX
product code JCX- Death
- 11
- Malfunction
- 838
- Other
- 1
- Total
- 850
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.