510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K910584Substantially Equivalent

One Step Button(tm)

Applied Medical Technologies, Independence OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K910584 is the FDA 510(k) clearance record for ONE STEP BUTTON(TM), a class II device, cleared for Applied Medical Technologies on under FDA product code KGC (Tube, Gastro-Enterostomy). FDA records list 24 510(k) clearances for Applied Medical Technologies, from to . As of , FDA records show 6 recalls naming K910584.

Clearance record

Decision date
Received
(101 days to decision)
Product code
KGC Tube, Gastro-Enterostomy
Regulation
21 CFR 876.5980
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Applied Medical Technologies 6100 W. Creek Rd., Independence OH
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