Omnisure Urethral Sling, Model OTK52

Q: What is the product code of K092203?

The FDA product code is OTN – Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator, a Class II (moderate risk) device regulated under 21 CFR 878.3300.

FDA 510(k) K092203 · Mpathy Medical Devices, Ltd.

Substantially Equivalent

510(k) numberK092203

Submission

Device name: Omnisure Urethral Sling, Model OTK52
Applicant: Mpathy Medical Devices, Ltd.
Glasgow, GB
Received: July 22, 2009
Decision date: August 12, 2009
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: OTN – Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator
Device class: Class II (moderate risk)
Regulation: 21 CFR 878.3300
Specialty: General, Plastic Surgery
Implant: Yes

Surgical treatment of female stress urinary incontinence due to intrinsic sphincter deficiency (isd) and/or urethral hypermobility

Other 510(k)s with product code OTN

510(k)	Device	Applicant	Decision
K231549	Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemOTN · Special	Boston Scientific Corporation	06/29/2023SE
K222293	ArcSP Suprapubic Sling SystemOTN · Special	Urocure, LLC	09/21/2022SE
K222468	ArcTO Transobturator Sling SystemOTN · Special	Urocure, LLC	09/15/2022SE
K211975	Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara…OTN · Special	Caldera Medical, Inc.	11/10/2021SE
K211223	Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemOTN · Traditional	Boston Scientific Corporation	07/21/2021SE
K210087	Athena Surgical RMUS SystemOTN · Traditional	Athena Surgical, LLC	04/12/2021SE
K201686	GYNECARE TVT System, GYNECARE TVT with Abdominal Guides System, GYNECARE TVT…OTN · Traditional	ETHICON, Inc.	09/17/2020SE
K183134	ArcTV Transvaginal Sling SystemOTN · Traditional	Urocure, LLC	02/07/2019SE
K162201	Desara TV, Desara Blue TVOTN · Traditional	Caldera Medical, Inc.	01/11/2017SE
K140843	Desara Blue Ov, Desara Blue SSOTN · Special	Caldera Medical	07/01/2014SE

More from Caldera Medical

510(k)	Device	Decision
K092207	Restorelle Polypropylene MeshOTP · Special	08/04/2009SE
K091180	Minitape Urethral SlingPAH · Special	07/14/2009SE
K073647	Minitape Extra Urethral SlingOTN · Special	03/03/2008SE
K073646	Minitape Urethral SlingPAH · Special	02/25/2008SE
K053361	Modification to: Minimesh Polypropylene MeshOTO · Special	02/06/2006SE
K041632	Minimesh Polypropylene MeshOTO · Traditional	11/17/2004SE

Questions and answers

When was Omnisure Urethral Sling, Model OTK52 cleared by the FDA?

Omnisure Urethral Sling, Model OTK52 (K092203) received a 510(k) decision of Substantially Equivalent on August 12, 2009, 21 days after the submission was received.

What is the product code of K092203?

The FDA product code is OTN – Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator, a Class II (moderate risk) device regulated under 21 CFR 878.3300.