Exair Anterior and Posterior Prolapse Repair Systems

Q: What is the product code of K083499?

The FDA product code is OTP – Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed, a Class III (high risk) device regulated under 21 CFR 884.5980.

FDA 510(k) K083499 · Coloplast A/S

Substantially Equivalent

510(k) numberK083499

Submission

Device name: Exair Anterior and Posterior Prolapse Repair Systems
Applicant: Coloplast A/S
Minneapolis, MN, US
Received: November 25, 2008
Decision date: May 8, 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: OTP – Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed
Device class: Class III (high risk)
Regulation: 21 CFR 884.5980
Specialty: Obstetrics/Gynecology
Implant: Yes

Tissue reinforcement of the fibromuscular layer of the pelvic floor when surgical treatment is indicated; Procedures include anterior and posterior vaginal wall prolapse repair and vaginal apical or uterine prolapse repair performed transvaginally

Other 510(k)s with product code OTP

510(k)	Device	Applicant	Decision
K122459	Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal Support SystemOTP · Abbreviated	Boston Scientific Corporation	12/13/2012SE
K121612	Elevate Prolapse Repair Systems-Apical Needle Passer Sheath ModificationOTP · Special	American Medical Systems	07/20/2012SE
K112842	Ams Elevate PCOTP · Special	American Medical Systems, Inc.	10/25/2011SE
K103426	Lite Pelvic Floor Repair KitsOTP · Abbreviated	Boston Scientific Corp	09/14/2011SE
K112386	Exair Anterior and Posterior Prolapse Repair SystemOTP · Special	Coloplast Corp.	09/08/2011SE
K102815	Surelift Prolapse SystemOTP · Traditional	Neomedic International	07/07/2011SE
K111118	Ams Elevate PC Apical and Posterior ( and Anterior and Apical) Prolapse Repair System…OTP · Special	American Medical Systems	07/01/2011SE
K092207	Restorelle Polypropylene MeshOTP · Special	Mpathy Medical Devices, Inc.	08/04/2009SE
K091131	Pelvic Floor Repair SystemOTP · Abbreviated	Boston Scientific	05/08/2009SE
K090713	Elevate Prolapse Repair System with PC Coated Intepro Lite- Apical and Posterior…OTP · Special	American Medical Systems, Inc.	04/02/2009SE

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Questions and answers

When was Exair Anterior and Posterior Prolapse Repair Systems cleared by the FDA?

Exair Anterior and Posterior Prolapse Repair Systems (K083499) received a 510(k) decision of Substantially Equivalent on May 8, 2009, 164 days after the submission was received.

What is the product code of K083499?

The FDA product code is OTP – Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed, a Class III (high risk) device regulated under 21 CFR 884.5980.