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

Monitor, Penile Tumescence

Unknown
FDA source (opens on fda.gov)

LIL is the FDA product code for Monitor, Penile Tumescence. As of , FDA records hold 26 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
LIL
Device name
Monitor, Penile Tumescence
Device class
Unclassified
Review panel
Unknown
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
26
Ingested recalls
0

Clearances, product code LIL

By decision year
26 clearances under product code LIL with a decision year between 1981 and 2006, 1983 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code LIL by decision year
YearClearances
19811
19822
19835
19843
19851
19871
19882
19921
19941
19952
19981
19991
20001
20031
20063

Applicants with the most clearances

Product code LIL
Applicants holding the most 510(k) clearances under product code LIL
ApplicantClearances
Dacomed Corp.4
Biorem2
Farrall Instruments, Inc.2
Life-Tech Intl., Inc.2
Medical Monitoring Systems, Inc.2
Behavioral Technology, Inc.1
Browne Medical, Inc.1
C.R. Bard Inc1
Compass Medical Technologies, Inc.1
Laborie Medical Tech Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code