Medline Gastrostomy Tube
FDA 510(k) K073718 · Medline Industries, Inc.
510(k) numberK073718
Submission
- Device name
- Medline Gastrostomy Tube
- Applicant
- Medline Industries, Inc.
Mundelein, IL, US - Received
- December 31, 2007
- Decision date
- March 19, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KGC – Tube, Gastro-Enterostomy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.5980
- Specialty
- Gastroenterology, Urology
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Questions and answers
When was Medline Gastrostomy Tube cleared by the FDA?
Medline Gastrostomy Tube (K073718) received a 510(k) decision of Substantially Equivalent on March 19, 2008, 79 days after the submission was received.
What is the product code of K073718?
The FDA product code is KGC – Tube, Gastro-Enterostomy, a Class II (moderate risk) device regulated under 21 CFR 876.5980.