FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)
K Number: K252412
·
Decision Oct 31, 2025
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
12
Review Days
91
Basic Information
- Device Name
- Voyant® Electrosurgical Generator (EA030/Electrosurgical Generator)
- K Number
- K252412
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Applied Medical Resources Corporation
- Date Received
- August 1, 2025
- Decision Date
- October 31, 2025
- Product Code
- GEI
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GEI), ordered by most recent decision date.
Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CoolSeal Generator® (CSL-200-90)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NEUROMARK System (NMK00301)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LAP-iX2N
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MILAN System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Applied Medical Resources Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K260982 | Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted wound protector-retractor, flexible, small (cl301);Alexis lighted wound protector-retractor, flexible, medium (cl302);Alexis lighted wound protector-retractor, flexible, large (cl303);Alexis lighted wound protector-retractor, rigid, small (cl401);Alexis lighted wound protector-retractor, rigid, medium (cl402); Alexis lighted wound protector-retractor, rigid, large (cl403) | Apr 24, 2026 | Substantially Equivalent |
| K253531 | Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302) | Feb 23, 2026 | Substantially Equivalent |
| K232880 | Inzii Ripstop Redeployable Retrieval System | Nov 1, 2023 | Substantially Equivalent |
| K222284 | Voyant Maryland Fusion device with Single-Step Activation (EB212, EB213, EB214) | Oct 14, 2022 | Substantially Equivalent |
| K220969 | GelPOINT V-Path Vaginal Access System | Sep 16, 2022 | Substantially Equivalent |
| K211043 | Alexis Contained Extraction System | Mar 31, 2022 | Substantially Equivalent |
| K202049 | Python Catheter/Over-the-Wire Latis Graft Cleaning Catheter | Sep 7, 2021 | Substantially Equivalent |
| K190331 | Applied Medical Laparoscopic Linear Cutter | Nov 22, 2019 | Substantially Equivalent |
| K180699 | Voyant Open Fusion Device | Apr 13, 2018 | Substantially Equivalent |
| K172624 | Voyant 5mm Fusion Device | Feb 13, 2018 | Substantially Equivalent |