510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K140977Substantially Equivalent

Evotech Ecr

Advanced Sterilization Products, Irvin CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K140977 is the FDA 510(k) clearance record for EVOTECH ECR, a class II device, cleared for Advanced Sterilization Products on under FDA product code FEB (Accessories, Cleaning, For Endoscope). FDA's definition for product code FEB reads: "If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at...". FDA records list 59 510(k) clearances for Advanced Sterilization Products, from to . As of , FDA records show 3 recalls naming K140977.

Clearance record

Decision date
Received
(250 days to decision)
Product code
FEB Accessories, Cleaning, For Endoscope
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Advanced Sterilization Products 33 Technology Dr., Irvin CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code FEB

Trailing 12 months

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

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