510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K892667Substantially Equivalent

Saf-T-Shunt Silicone Rubber U, Prod. Code S-313

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

K892667 is the FDA 510(k) clearance record for SAF-T-SHUNT SILICONE RUBBER U, PROD. CODE S-313, a class II device, cleared for Akcess Medical Products, Inc. on under FDA product code FKN (Adaptor, Shunt). FDA records list 36 510(k) clearances for Akcess Medical Products, Inc., from to . As of , FDA records show no recalls naming K892667.

Clearance record

Decision date
Received
(21 days to decision)
Product code
FKN Adaptor, Shunt
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 FKN

Trailing 12 months

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

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