Endoluminal Access Tube

FDA 510(k) K941228 · Med Institute, Inc.

Unknown

510(k) numberK941228

Submission

Device name
Endoluminal Access Tube
Applicant
Med Institute, Inc.
West Lafayette, IN, US
Received
March 15, 1994
Decision date
September 27, 1995
Decision
Unknown (SESK)
Type
Traditional 510(k)
Summary
510(k) summary 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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Questions and answers

When was Endoluminal Access Tube cleared by the FDA?

Endoluminal Access Tube (K941228) received a 510(k) decision of Unknown on September 27, 1995, 561 days after the submission was received.

What is the product code of K941228?

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