510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K843975Substantially Equivalent

9 French 42Long Polyurethane Graduated Enteric Fe

Superior Plastic Products Corp., Cumberland RI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K843975 is the FDA 510(k) clearance record for 9 FRENCH 42LONG POLYURETHANE GRADUATED ENTERIC FE, a class II device, cleared for Superior Plastic Products Corp. on under FDA product code KNT (Tubes, Gastrointestinal (And Accessories)). FDA records list 15 510(k) clearances for Superior Plastic Products Corp., from to . As of , FDA records show no recalls naming K843975.

Clearance record

Decision date
Received
(40 days to decision)
Product code
KNT Tubes, Gastrointestinal (And Accessories)
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Superior Plastic Products Corp. Columbia Industrial Park, Cumberland RI
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