MEGA 2000 SOFT DUAL CORD PATIENT RETURN ELECTRODE PAD— 510(k) K031285
Substantially EquivalentMegadyne Medical Products, Inc.
FDA 510(k) clearance K031285 for MEGA 2000 SOFT DUAL CORD PATIENT RETURN ELECTRODE PAD, Substantially Equivalent on 2003-05-19. 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
- Traditional
- Location
- Cincinnati, OH, 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 K031285
K-number listed on FDA's recall record- Z-2250-2024 — Brand Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Model/Catalog Number: 0835 Software Version: N/A Product Description: Reusable Patient Return Electrode, Mega Soft, Dual Cord, Adult, For Patients Weighing over 25lbs. (11.4kg), 117cm Long x 51cm Wide x 1.25cm Thick Component: No
- Z-1996-2023 — MEGADYNE MEGA SOFT Dual Reusable 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 K031285.
Data sourced from openFDA. This site is unofficial and independent of the FDA.