510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
LHCClass I

Warmer, Irrigation Solution

21 CFR 890.5950 / Physical Medicine
FDA source (opens on fda.gov)

LHC is the FDA product code for Warmer, Irrigation Solution, a class I device type, regulated under 21 CFR 890.5950. As of , FDA records hold 24 510(k) clearances under this code, the most recent dated , and 10 recalls.

Classification record

Product code
LHC
Device name
Warmer, Irrigation Solution
Regulation
21 CFR 890.5950
Device class
Class I
Review panel
Physical Medicine
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
24
Ingested recalls
10

Clearances, product code LHC

By decision year
24 clearances under product code LHC with a decision year between 1981 and 2016, 2002 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code LHC by decision year
YearClearances
19811
19831
19841
19882
19921
19942
19951
19971
19981
20001
20024
20051
20081
20091
20142
20151
20162

Applicants with the most clearances

Product code LHC
Applicants holding the most 510(k) clearances under product code LHC
ApplicantClearances
Microtek Medical LLC4
O.R. Solutions, Inc.4
C Change Surgical LLC2
American Hydro-Surgical Instruments, Inc.1
Augustine Medical, Inc.1
Cabot Medical Corp.1
Getinge Sourcing, LLC1
Johnson Flexgroup1
Kmi Kolster Methods, Inc.1
Mac Medical1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 27 companies shown, in name order