IRRIGATION/ASPIRATION INSTRUMENT— 510(k) K942306
Substantially EquivalentMegadyne Medical Products, Inc.
FDA 510(k) clearance K942306 for IRRIGATION/ASPIRATION INSTRUMENT, Substantially Equivalent on 1994-09-23. Applicant: Megadyne Medical Products, Inc.. Device class: 2.
Clearance details
- Applicant
- Megadyne Medical Products, Inc.
- Product code
- Code GCJ
- Device class
- Class 2
- Regulation
- 21 CFR 876.1500
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Draper, UT, US
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More 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 GCJ
product code GCJ- Death
- 39
- Injury
- 1,638
- Malfunction
- 28,216
- Other
- 11
- Total
- 29,904
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.