Stoma Measuring Device

FDA 510(k) K923692 · Applied Medical Technologies

Unknown

510(k) numberK923692

Submission

Device name
Stoma Measuring Device
Applicant
Applied Medical Technologies
Independence, OH, US
Received
July 23, 1992
Decision date
May 7, 1993
Decision
Unknown (SEKD)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
KNT – Tubes, Gastrointestinal (And Accessories)
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5980
Specialty
Gastroenterology, Urology

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More from Degania Silicone , Ltd.

510(k)DeviceDecision
K971434A.M.T. G-Tube Balloon Replacement Gastrostomy Feeding DeviceKNT · Traditional 08/17/1998SE
K972478Pre-Loaded Replacement G-Tubes and AccessoriesKNT · Traditional 02/09/1998SE
K973893Amt Balloon Stoma Measuring Devices, Amt Balloon Measuring Device, Amt Balloon Measuring…KNT · Traditional 12/19/1997SE
K971757Low Profile Feeding Set AccessoryKNT · Traditional 11/07/1997SE
K971758Cauterization Smoke EvacuatorGEI · Traditional 07/21/1997SE
K961345Domed Percutaneous Endoscopic Gastrostomy(P.E.G.) Feeding TubeKNT · Traditional 09/17/1996SE
K960232Endoscopic Access DeviceGCJ · Traditional 03/21/1996SE
K945618Gastrointestinal Tubes & AccessoriesKNT · Traditional 10/12/1995SE
K946140PRG ButtonKNT · Traditional 08/28/1995SE
K923488Gastranimal Percutaneous Replacement GastroomyKNT · Traditional 07/20/1995SE

Questions and answers

When was Stoma Measuring Device cleared by the FDA?

Stoma Measuring Device (K923692) received a 510(k) decision of Unknown on May 7, 1993, 288 days after the submission was received.

What is the product code of K923692?

The FDA product code is KNT – Tubes, Gastrointestinal (And Accessories), a Class II (moderate risk) device regulated under 21 CFR 876.5980.