MACROLYTE DISPERSIVE ELECTRODE— 510(k) K120476
Substantially EquivalentConmed Corporation
FDA 510(k) clearance K120476 for MACROLYTE DISPERSIVE ELECTRODE, Substantially Equivalent on 2012-06-12. Applicant: Conmed Corporation. Device class: 2.
Clearance details
- Applicant
- Conmed 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
- Centennial, CO, US
Recent devices under product code GEI
view allMore clearances from Conmed Corporation
view allAdverse 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 →
Recalls naming K120476
K-number listed on FDA's recall record- Z-2545-2019 — LEEP Return Patient Pads (10/ box) Model # 6050Pl used in electrosurgical procedures.
- Z-1719-2014 — MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. The device is applied to the patient during electrosurgical procedures to provide a path for RF current to leave the patient and return to the generator.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120476.
Data sourced from openFDA. This site is unofficial and independent of the FDA.