Desara TV, Desara Blue TV

Q: What is the product code of K162201?

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) K162201 · Caldera Medical, Inc.

Substantially Equivalent

510(k) numberK162201

Submission

Device name: Desara TV, Desara Blue TV
Applicant: Caldera Medical, Inc.
Agoura Hills, CA, US
Received: August 5, 2016
Decision date: January 11, 2017
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement 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
K140843	Desara Blue Ov, Desara Blue SSOTN · Special	Caldera Medical	07/01/2014SE
K131229	Sparc System and Monarc, Monarc, and Monarc C SystemsOTN · Special	American Medical Systems	12/05/2013SE

More from American Medical Systems

510(k)	Device	Decision
K233500	Benesta Tissue Removal DeviceHIH · Special	11/30/2023SE
K211975	Desara TV EZ 3.0 System, Desara Blue TV EZ 3.0 System, Desara TV EZ 2.7 System, Desara…OTN · Special	11/10/2021SE
K192811	BenestaTM Tissue Removal DeviceHIH · Traditional	10/23/2020SE
K192822	Benesta HysteroscopeHIH · Traditional	09/09/2020SE
K193603	Benesta Medical Sterilization TrayKCT · Traditional	07/20/2020SE
K191416	Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling…PAH · Traditional	02/07/2020SE
K172614	Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator…PWJ · Traditional	05/04/2018SE
K150023	Vertessa Lite Y-MeshOTO · Traditional	04/06/2015SE
K150016	Vertessa LiteOTO · Traditional	04/06/2015SE
K140843	Desara Blue Ov, Desara Blue SSOTN · Special	07/01/2014SE

Questions and answers

When was Desara TV, Desara Blue TV cleared by the FDA?

Desara TV, Desara Blue TV (K162201) received a 510(k) decision of Substantially Equivalent on January 11, 2017, 159 days after the submission was received.

What is the product code of K162201?

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.