510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K894653Substantially Equivalent

No. 87500-Nuport Peg Gastrostomy Tube Kit 22 Fr

Superior Biosystems, Inc., Cumberland RI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894653 is the FDA 510(k) clearance record for NO. 87500-NUPORT PEG GASTROSTOMY TUBE KIT 22 FR, a class II device, cleared for Superior Biosystems, Inc. on under FDA product code KGC (Tube, Gastro-Enterostomy). FDA records list one 510(k) clearance for Superior Biosystems, Inc. As of , FDA records show no recalls naming K894653.

Clearance record

Decision date
Received
(150 days to decision)
Product code
KGC Tube, Gastro-Enterostomy
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Superior Biosystems, Inc. Cumberland Industrial Park, Cumberland RI
Third party review
No

Clearances, product code KGC

Trailing 12 months

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

FDA records show no clearances under product code KGC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KGC, 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