MEGA SOFT UNIVERSAL PATIENT RETURN ELECTRODE— 510(k) K133726
Substantially EquivalentMegadyne Medical Products, Inc.
FDA 510(k) clearance K133726 for MEGA SOFT UNIVERSAL PATIENT RETURN ELECTRODE, Substantially Equivalent on 2014-01-24. Applicant: Megadyne Medical Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Megadyne Medical Products, Inc.
- 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
- Draper, UT, US
Recent devices under product code GEI
view allMore clearances from Megadyne Medical Products, Inc.
view all- K233644 — Megadyne Patient Return Electrode Pad - Universal Dual (model 0846), Megadyne Patient Return Electrode Pad - Universal Plus (model 0847), Megadyne Patient Return Electrode Pad - Universal Dual Plus (model 0848)
- K213696 — ETHICON Megadyne Electrosurgical Generator
- K200250 — Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor
- K193145 — Ethicon Megadyne Electrosurgical Generator, Bipolar Footswitch
- K191328 — Megadyne Foot Switch
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 →
Recalls naming K133726
K-number listed on FDA's recall record- Z-0597-2024 — Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reusable Patient Return Electrode
- Z-1998-2023 — MEGADYNE MEGA SOFT Universal Patient Return Electrode. used during electrosurgery
- Z-1999-2023 — MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode. used during electrosurgery
- Z-2000-2023 — MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode. used during electrosurgery
- Z-2001-2023 — MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode. used during electrosurgery
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K133726.
Data sourced from openFDA. This site is unofficial and independent of the FDA.