OTOClass II

Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed

21 CFR 878.3300 / General, Plastic Surgery

OTO is the FDA product code for Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed, a class II device type, regulated under 21 CFR 878.3300. FDA's definition for this code reads: "Bridging material to attach the vaginal apex to the anterior longitudinal ligament of the sacrum; Procedures include abdominal sacrocolpopexy and laparoscopic sacrocolpopexy". As of 2026-09-10, FDA records hold 23 510(k) clearances under this code, the most recent dated 2017-12-15, and one recall.

Classification record

Product code: OTO
Device name: Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed
FDA definition: Bridging material to attach the vaginal apex to the anterior longitudinal ligament of the sacrum; Procedures include abdominal sacrocolpopexy and laparoscopic sacrocolpopexy.
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: 23
Ingested recalls: 1

Clearances, product code OTO

By decision year

23 clearances under product code OTO with a decision year between 2001 and 2017, 2012 the highest year at 7.

Show the numbers

510(k) clearances under FDA product code OTO by decision year
Year	Clearances
2001	1
2002	1
2004	1
2005	2
2006	1
2009	1
2011	1
2012	7
2013	4
2014	1
2015	2
2017	1

Applicants with the most clearances

Product code OTO

Applicants holding the most 510(k) clearances under product code OTO
Applicant	Clearances
MEDLINE INDUSTRIES, LP - Northfield	6
Caldera Medical, Inc.	5
American Medical Systems, Inc.	3
Boston Scientific Corporation	2
C.R. Bard Inc	2
Mpathy Medical Devices, Ltd.	2
Ethicon, Inc	1
Gynecare, A Div. of Ethicon, Inc.	1
Proxy Biomedical Ltd.	1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 15 companies shown, in name order