510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K910502Substantially Equivalent

Vessel Dilators

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

K910502 is the FDA 510(k) clearance record for VESSEL DILATORS, a class II device, cleared for Akcess Medical Products, Inc. on under FDA product code FKA (Dilator, Vessel). FDA records list 36 510(k) clearances for Akcess Medical Products, Inc., from to . As of , FDA records show no recalls naming K910502.

Clearance record

Decision date
Received
(83 days to decision)
Product code
FKA Dilator, Vessel
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Akcess Medical Products, Inc. 789 Jersey Ave., New Brunswick NJ
Third party review
No

Clearances, product code FKA

Trailing 12 months

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

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