MEGA 2000 SOFT PATIENT RETURN ELECTRODE PAD— 510(k) K021077
Substantially EquivalentMegadyne Medical Products, Inc.
FDA 510(k) clearance K021077 for MEGA 2000 SOFT PATIENT RETURN ELECTRODE PAD, Substantially Equivalent on 2002-04-17. 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 K021077
K-number listed on FDA's recall record- Z-2249-2024 — Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Model/Catalog Number: 0830 Software Version: N/A Product Description: Reusable Patient Return Electrode, Mega Soft, Single Cord, Adult, For Patients Weighing over 25lbs (11.4Kg), 117cm Long x 51cm Wide x 1.25cm Thick Component: No
- Z-1995-2023 — MEGADYNE MEGA SOFT 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 K021077.
Data sourced from openFDA. This site is unofficial and independent of the FDA.