510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K981323Substantially Equivalent

Compat Mini-G Replacement Gastrostomy Tube

Novartis Nutrition Corp., Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981323 is the FDA 510(k) clearance record for COMPAT MINI-G REPLACEMENT GASTROSTOMY TUBE, a class II device, cleared for Novartis Nutrition Corp. on under FDA product code KNT (Tubes, Gastrointestinal (And Accessories)). FDA records list 6 510(k) clearances for Novartis Nutrition Corp., from to . As of , FDA records show no recalls naming K981323.

Clearance record

Decision date
Received
(179 days to decision)
Product code
KNT Tubes, Gastrointestinal (And Accessories)
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Novartis Nutrition Corp. 5320 W. 23rd St., Minneapolis MN
510(k) summary
Summary
Third party review
No

Clearances, product code KNT

Trailing 12 months
2 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 20260
October 20260