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

Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator

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

OTN is the FDA product code for Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator, a class II device type, regulated under 21 CFR 878.3300. FDA's definition for this code reads: "Surgical treatment of female stress urinary incontinence due to intrinsic sphincter deficiency (isd) and/or urethral hypermobility". As of , FDA records hold 65 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
OTN
Device name
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
FDA definition
Surgical treatment of female stress urinary incontinence due to intrinsic sphincter deficiency (isd) and/or urethral hypermobility
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
65
Ingested recalls
1

Clearances, product code OTN

By decision year
65 clearances under product code OTN with a decision year between 1996 and 2023, 2004 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code OTN by decision year
YearClearances
19961
19972
19983
20014
20026
20034
20047
20055
20061
20072
20083
20092
20105
20114
20121
20135
20141
20171
20191
20201
20213
20222
20231

Applicants with the most clearances

Product code OTN
Applicants holding the most 510(k) clearances under product code OTN
ApplicantClearances
American Medical Systems, Inc.14
Caldera Medical, Inc.8
Ethicon, Inc6
Boston Scientific Corporation5
Mentor4
Island Biosurgical, Inc.3
Urocure, LLC3
C.R. Bard Inc2
Generic Medical Device, Inc.2
Influence, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 24 companies shown, in name order