Voyant Open Fusion Device— 510(k) K180699
Substantially EquivalentApplied Medical Resources Corporation
FDA 510(k) clearance K180699 for Voyant Open Fusion Device, Substantially Equivalent on 2018-04-13. Applicant: Applied Medical Resources Corporation. Device class: 2.
Clearance details
- Applicant
- Applied Medical Resources Corporation
- Product code
- Code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Rancho Santa, CA, US
Recent devices under product code GEI
view allMore clearances from Applied Medical Resources Corporation
view all- K260982 — Alexis lighted wound protector-retractor, flexible, extra small (cl312) +6 more
- K253531 — Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402) +1 more
- K252412 — Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)
- K232880 — Inzii Ripstop Redeployable Retrieval System
- K222284 — Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214)
Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
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.