CAUTERIZATION SMOKE EVACUATOR— 510(k) K971758
Substantially EquivalentApplied Medical Technologies
FDA 510(k) clearance K971758 for CAUTERIZATION SMOKE EVACUATOR, Substantially Equivalent on 1997-07-21. Applicant: Applied Medical Technologies. Device class: 2.
Clearance details
- Applicant
- Applied Medical Technologies
- 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
- Cleveland, OH, US
Recent devices under product code GEI
view allMore clearances from Applied Medical Technologies
view all- K971434 — A.M.T. G-TUBE BALLOON REPLACEMENT GASTROSTOMY FEEDING DEVICE
- K972478 — PRE-LOADED REPLACEMENT G-TUBES AND ACCESSORIES
- K973893 — AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON MEASURING DEVICE WITH STOP VALVE, AMY BAE
- K971757 — LOW PROFILE FEEDING SET ACCESSORY
- K961345 — DOMED PERCUTANEOUS ENDOSCOPIC GASTROSTOMY(P.E.G.) FEEDING TUBE
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.