510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964131Substantially Equivalent

Endoscope

Akos Biomedical, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964131 is the FDA 510(k) clearance record for ENDOSCOPE, a class II device, cleared for Akos Biomedical, Inc. on under FDA product code FAM (Sigmoidoscope And Accessories, Flexible/Rigid). FDA's definition for product code FAM reads: "to examine and perform procedures within the sigmoid (descending) colon". FDA records list one 510(k) clearance for Akos Biomedical, Inc. As of , FDA records show no recalls naming K964131.

Clearance record

Decision date
Received
(255 days to decision)
Product code
FAM Sigmoidoscope And Accessories, Flexible/Rigid
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Akos Biomedical, Inc. 6450 Lusk Blvd., Suite 109, San Diego CA
510(k) summary
Summary
Third party review
No

Clearances, product code FAM

Trailing 12 months

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

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