510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K842174Substantially Equivalent

Percutaneous Gastrostomy Tube

Mount Carmel Mercy Hospital, Detroit MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K842174 is the FDA 510(k) clearance record for PERCUTANEOUS GASTROSTOMY TUBE, a class II device, cleared for Mount Carmel Mercy Hospital on under FDA product code KNT (Tubes, Gastrointestinal (And Accessories)). FDA records list one 510(k) clearance for Mount Carmel Mercy Hospital. As of , FDA records show no recalls naming K842174.

Clearance record

Decision date
Received
(184 days to decision)
Product code
KNT Tubes, Gastrointestinal (And Accessories)
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Mount Carmel Mercy Hospital 6071 W. Outer Dr., Detroit MI
Third party review
No

Clearances, product code KNT

Trailing 12 months
3 clearances under product code KNT in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KNT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20261
September 20261
October 20260