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

Lavage, Jet

21 CFR 880.5475 / General Hospital
FDA source (opens on fda.gov)

FQH is the FDA product code for Lavage, Jet, a class II device type, regulated under 21 CFR 880.5475. As of , FDA records hold 53 510(k) clearances under this code, the most recent dated , and 29 recalls.

Classification record

Product code
FQH
Device name
Lavage, Jet
Regulation
21 CFR 880.5475
Device class
Class II
Review panel
General Hospital
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
53
Ingested recalls
29

Clearances, product code FQH

By decision year
53 clearances under product code FQH with a decision year between 1979 and 2026, 1997 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code FQH by decision year
YearClearances
19791
19824
19831
19862
19873
19911
19932
19942
19951
19975
19982
20001
20012
20021
20031
20041
20061
20071
20093
20112
20121
20151
20161
20203
20211
20224
20233
20262

Applicants with the most clearances

Product code FQH
Applicants holding the most 510(k) clearances under product code FQH
ApplicantClearances
IrriMAX Corporation4
Erbe USA Inc3
Hydrocision, Inc.3
Stryker Corp.3
BD2
Howmedica Corp.2
Micro-Aire Surgical Instruments, Inc.2
Next Science, LLC2
Smith & Nephew, Inc.2
Ackrad Laboratories1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 118 companies shown, in name order