510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K893209Substantially Equivalent

Entera-Flo Spike Set

Delmed, Inc., New Brunswick NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K893209 is the FDA 510(k) clearance record for ENTERA-FLO SPIKE SET, a class II device, cleared for Delmed, Inc. on under FDA product code KNT (Tubes, Gastrointestinal (And Accessories)). FDA records list 27 510(k) clearances for Delmed, Inc., from to . As of , FDA records show no recalls naming K893209.

Clearance record

Decision date
Received
(88 days to decision)
Product code
KNT Tubes, Gastrointestinal (And Accessories)
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Delmed, Inc. 120 Albany St., New Brunswick NJ
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