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

Tissue Expander And Accessories

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FDA source (opens on fda.gov)

LCJ is the FDA product code for Tissue Expander And Accessories. As of , FDA records hold 55 510(k) clearances under this code, the most recent dated , and 21 recalls.

Classification record

Product code
LCJ
Device name
Tissue Expander And Accessories
Device class
Unclassified
Review panel
Unknown
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
55
Ingested recalls
21

Clearances, product code LCJ

By decision year
55 clearances under product code LCJ with a decision year between 1977 and 2026, 1984 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code LCJ by decision year
YearClearances
19771
19791
19801
19845
19854
19864
19874
19892
19902
19912
19961
19984
19991
20011
20071
20111
20121
20131
20143
20152
20163
20183
20233
20241
20252
20261

Applicants with the most clearances

Product code LCJ
Applicants holding the most 510(k) clearances under product code LCJ
ApplicantClearances
Mentor9
Mentor Worldwide, LLC8
Mcghan Medical Corp.7
Specialty Surgical Products, Inc.4
Allergan3
Cox-Uphuff Intl.2
Heyer Schulte Corp.2
Medical Engineering Corp.2
Sientra, Inc.2
Surgitek2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order