510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K163424Substantially Equivalent

AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON

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

K163424 is the FDA 510(k) clearance record for AquaShield System - PENTAX, AquaShield System CO2 - PENTAX, AquaShield System CO2 - FUJINON, a class II device, cleared for United State Endoscopy Group, Inc. on under FDA product code FEQ (Pump, Air, Non-Manual, For Endoscope). FDA records list one 510(k) clearance for United State Endoscopy Group, Inc. As of , FDA records show no recalls naming K163424.

Clearance record

Decision date
Received
(29 days to decision)
Product code
FEQ Pump, Air, Non-Manual, For Endoscope
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
United State Endoscopy Group, Inc. 5976 Heisley Rd., Mentor OH
510(k) summary
Statement
Third party review
No

Clearances, product code FEQ

Trailing 12 months

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

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