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

Mesh, Surgical, For Stress Urinary Incontinence, Male

21 CFR 878.3300 / General, Plastic Surgery
FDA source (opens on fda.gov)

OTM is the FDA product code for Mesh, Surgical, For Stress Urinary Incontinence, Male, a class II device type, regulated under 21 CFR 878.3300. FDA's definition for this code reads: "surgical treatment of male stress urinary incontinence post-prostatectomy". As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
OTM
Device name
Mesh, Surgical, For Stress Urinary Incontinence, Male
FDA definition
surgical treatment of male stress urinary incontinence post-prostatectomy
Regulation
21 CFR 878.3300
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k)
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
12
Ingested recalls
1

Clearances, product code OTM

By decision year
12 clearances under product code OTM with a decision year between 2006 and 2024, 2006 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code OTM by decision year
YearClearances
20063
20081
20091
20101
20111
20121
20181
20211
20231
20241

Applicants with the most clearances

Product code OTM
Applicants holding the most 510(k) clearances under product code OTM
ApplicantClearances
MEDLINE INDUSTRIES, LP - Northfield6
Boston Scientific Corporation3
American Medical Systems, Inc.1
CL MEDICAL Inc.1
Specialities Remeex International, S.L.1

Companies listing this code with FDA

Companies whose registered establishments list this code