GMD Universal Sling, Model Product Code 1010 and 1020

FDA 510(k) K083471 · Generic Medical Device, Inc.

Substantially Equivalent

510(k) numberK083471

Submission

Device name
GMD Universal Sling, Model Product Code 1010 and 1020
Applicant
Generic Medical Device, Inc.
Gig Harbor, WA, US
Received
November 24, 2008
Decision date
March 3, 2009
Decision
Substantially Equivalent (SESE)
Type
Traditional 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)DeviceApplicantDecision
K231549Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemOTN · Special Boston Scientific Corporation06/29/2023SE
K222293ArcSP Suprapubic Sling SystemOTN · Special Urocure, LLC09/21/2022SE
K222468ArcTO Transobturator Sling SystemOTN · Special Urocure, LLC09/15/2022SE
K211975Desara 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
K211223Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra SystemOTN · Traditional Boston Scientific Corporation07/21/2021SE
K210087Athena Surgical RMUS SystemOTN · Traditional Athena Surgical, LLC04/12/2021SE
K201686GYNECARE TVT™ System, GYNECARE TVT™ with Abdominal Guides System, GYNECARE TVT™…OTN · Traditional ETHICON, Inc.09/17/2020SE
K183134ArcTV Transvaginal Sling SystemOTN · Traditional Urocure, LLC02/07/2019SE
K162201Desara TV, Desara Blue TVOTN · Traditional Caldera Medical, Inc.01/11/2017SE
K140843Desara Blue Ov, Desara Blue SSOTN · Special Caldera Medical07/01/2014SE

More from Caldera Medical

510(k)DeviceDecision
K111219GMD Universal Urinary Incontinence SlingOTN · Traditional 06/30/2011SE
K070018Universal Surgical Mesh, Model 100FTL · Traditional 04/27/2007SE
K063429GMD Universal Circumcision Clamp, Model 200HFX · Traditional 01/17/2007SE

Questions and answers

When was GMD Universal Sling, Model Product Code 1010 and 1020 cleared by the FDA?

GMD Universal Sling, Model Product Code 1010 and 1020 (K083471) received a 510(k) decision of Substantially Equivalent on March 3, 2009, 99 days after the submission was received.

What is the product code of K083471?

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.