510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K984168Substantially Equivalent

Barrett's Esophageal Cytology Device

United States Endoscopy Group, Inc., Mentor OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K984168 is the FDA 510(k) clearance record for BARRETT'S ESOPHAGEAL CYTOLOGY DEVICE, a class II device, cleared for United States Endoscopy Group, Inc. on under FDA product code FCF (Instrument, Biopsy, Mechanical, Gastrointestinal). FDA records list 94 510(k) clearances for United States Endoscopy Group, Inc., from to . As of , FDA records show no recalls naming K984168.

Clearance record

Decision date
Received
(382 days to decision)
Product code
FCF Instrument, Biopsy, Mechanical, Gastrointestinal
Regulation
21 CFR 876.1075
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
United States Endoscopy Group, Inc. 5976 Heisley Rd., Mentor OH
510(k) summary
Summary
Third party review
No

Clearances, product code FCF

Trailing 12 months

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

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