DeviceClearance

Product code FQH— General Hospital

HELIX HYDRO-JET

Classification name
Lavage, Jet
Device class
Class 2
Regulation
21 CFR 880.5475
Advisory panel
General Hospital
Total cleared
53
First cleared
Most recent

Market context for product code FQH

FDA has cleared 53 devices under product code FQH between 1979 and 2026, filed by 40 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code FQH

Adverse events under product code FQH

product code FQH
Injury
170
Malfunction
2,513
Other
1
Total
2,684

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code FQH

Data sourced from openFDA. This site is unofficial and independent of the FDA.