510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K904299Substantially Equivalent

Slim Line Retent Tip W/silicone Inflation Cuff

E-Z-EM, Inc, Worcester MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K904299 is the FDA 510(k) clearance record for SLIM LINE RETENT TIP W/SILICONE INFLATION CUFF, a class II device, cleared for E-Z-Em, Inc. on under FDA product code FGD (Catheter, Retention, Barium Enema With Bag). FDA records list 56 510(k) clearances for E-Z-Em, Inc., from to . As of , FDA records show no recalls naming K904299.

Clearance record

Decision date
Received
(69 days to decision)
Product code
FGD Catheter, Retention, Barium Enema With Bag
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
E-Z-Em, Inc. 373 Plantation St., Worcester MA
Third party review
No

Clearances, product code FGD

Trailing 12 months

FDA records hold no clearances under product code FGD in the trailing twelve months.

FDA records show no clearances under product code FGD in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code FGD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260