510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K832458Substantially Equivalent

Automatic Endoscope

American Endoscopy, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K832458 is the FDA 510(k) clearance record for AUTOMATIC ENDOSCOPE, a class II device, cleared for American Endoscopy, Inc. on under FDA product code NVE (Washer, Cleaner, Automated, Endoscope). FDA's definition for product code NVE reads: "This automated device is intended to be used to clean endoscopes. Endoscopes that are intended to be cleaned by the automated cleaner system should have been pre-cleaned and tested for leaks and lumen obstructions according to the...". FDA records list 19 510(k) clearances for American Endoscopy, Inc., from to . As of , FDA records show 2 recalls naming K832458.

Clearance record

Decision date
Received
(86 days to decision)
Product code
NVE Washer, Cleaner, Automated, Endoscope
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
American Endoscopy, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code NVE

Trailing 12 months

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

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