510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K954879Substantially Equivalent

Percutaneous Replacement Gastrostomy Feeding Catheter Tray (Modification)

United States Endoscopy Group, Inc., Mentor OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954879 is the FDA 510(k) clearance record for PERCUTANEOUS REPLACEMENT GASTROSTOMY FEEDING CATHETER TRAY (MODIFICATION), a class II device, cleared for United States Endoscopy Group, Inc. on under FDA product code KNT (Tubes, Gastrointestinal (And Accessories)). FDA records list 94 510(k) clearances for United States Endoscopy Group, Inc., from to . As of , FDA records show no recalls naming K954879.

Clearance record

Decision date
Received
(168 days to decision)
Product code
KNT Tubes, Gastrointestinal (And Accessories)
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
United States Endoscopy Group, Inc. 9300 Progress Pkwy., Mentor OH
510(k) summary
Statement
Third party review
No

Clearances, product code KNT

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