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

Counter, Sponge, Surgical

21 CFR 880.2740 / General Hospital
FDA source (opens on fda.gov)

LWH is the FDA product code for Counter, Sponge, Surgical, a class I device type, regulated under 21 CFR 880.2740. As of , FDA records hold 15 510(k) clearances under this code, the most recent dated , and 4 recalls.

Classification record

Product code
LWH
Device name
Counter, Sponge, Surgical
Regulation
21 CFR 880.2740
Device class
Class I
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
15
Ingested recalls
4

Clearances, product code LWH

By decision year
15 clearances under product code LWH with a decision year between 1979 and 2012, 2006 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code LWH by decision year
YearClearances
19791
19871
19911
19951
19971
19981
20063
20072
20091
20101
20122

Applicants with the most clearances

Product code LWH
Applicants holding the most 510(k) clearances under product code LWH
ApplicantClearances
Clearcount Medical Solutions, Inc.3
Devon Industries, Inc.2
Gauss Surgical, Inc.2
Gorsk, Inc.1
Haldor Advanced Technologies, Ltd.1
Markwell Intl., Inc.1
MEDLINE INDUSTRIES, LP - Northfield1
Michael Fischer Assoc.1
Rf Surgical Systems, Inc.1
Sage Products LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 46 companies shown, in name order