AMT BALLOON STOMA MEASURING DEVICES, AMT BALLOON MEASURING DEVICE, AMT BALLOON MEASURING DEVICE WITH STOP VALVE, AMY BAE— 510(k) K973893

Clearance details

Applicant

Applied Medical Technologies

Product code

Code KNT

Device class

Class 2

Regulation

21 CFR 876.5980

Advisory panel

Gastroenterology, Urology

Date received

1997-10-14

Decision date

1997-12-19

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Cleveland, OH, US

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• K971434 — A.M.T. G-TUBE BALLOON REPLACEMENT GASTROSTOMY FEEDING DEVICE1998-08-17
• K972478 — PRE-LOADED REPLACEMENT G-TUBES AND ACCESSORIES1998-02-09
• K971757 — LOW PROFILE FEEDING SET ACCESSORY1997-11-07
• K971758 — CAUTERIZATION SMOKE EVACUATOR1997-07-21
• K961345 — DOMED PERCUTANEOUS ENDOSCOPIC GASTROSTOMY(P.E.G.) FEEDING TUBE1996-09-17

Death

192

Injury

6,034

Malfunction

4,049

Other

1

Total

10,276

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →