510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN220025Unknown

Phagenyx System

Phagenesis Inc., Manchester, GB / Direct, Unknown
FDA source (opens on fda.gov)

DEN220025 is the FDA 510(k) clearance record for Phagenyx System, a class II device, cleared for Phagenesis Limited on under FDA product code QQG (Oropharyngeal Electrical Stimulator). FDA's definition for product code QQG reads: "An oropharyngeal electrical stimulator is a device that stimulates afferent nerve fibers of oropharyngeal mucosa. The device is intended to treat swallowing dysfunction. The device may incorporate a feeding tube". FDA records list one 510(k) clearance for Phagenesis Limited. As of , FDA records show no recalls naming DEN220025.

Clearance record

Decision date
Received
(150 days to decision)
Product code
QQG Oropharyngeal Electrical Stimulator
Regulation
21 CFR 874.5950
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Phagenesis Limited Unit 18, Enterprise House, Manchester, GB
Third party review
No

Clearances, product code QQG

Trailing 12 months

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

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