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

Finger Cot

21 CFR 880.6250 / General Hospital
FDA source (opens on fda.gov)

LZB is the FDA product code for Finger Cot, a class I device type, regulated under 21 CFR 880.6250. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
LZB
Device name
Finger Cot
Regulation
21 CFR 880.6250
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
5
Ingested recalls
1

Clearances, product code LZB

By decision year
5 clearances under product code LZB with a decision year between 1990 and 2005, 1990 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LZB by decision year
YearClearances
19901
19911
19981
20001
20051

Applicants with the most clearances

Product code LZB
Applicants holding the most 510(k) clearances under product code LZB
ApplicantClearances
Arthrex GmbH1
Bethel Latex Products, Inc.1
Digit-Pro1
Dongkuk Trading Co., Ltd.1
Tucker & Associates1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 69 companies shown, in name order