Ams Elevate PC Apical and Posterior ( and Anterior and Apical) Prolapse Repair System with Intepro Lite

Q: What is the product code of K111118?

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) K111118 · American Medical Systems

Substantially Equivalent

510(k) numberK111118

Submission

Device name: Ams Elevate PC Apical and Posterior ( and Anterior and Apical) Prolapse Repair System with Intepro Lite
Applicant: American Medical Systems
Minnetonka, MN, US
Received: April 21, 2011
Decision date: July 1, 2011
Decision: Substantially Equivalent (SESE)
Type: Special 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
K092207	Restorelle Polypropylene MeshOTP · Special	Mpathy Medical Devices, Inc.	08/04/2009SE
K091131	Pelvic Floor Repair SystemOTP · Abbreviated	Boston Scientific	05/08/2009SE
K083499	Exair Anterior and Posterior Prolapse Repair SystemsOTP · Traditional	Coloplast A/S	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

More from American Medical Systems, Inc.

510(k)	Device	Decision
K140679	Sureflex Lithotripsy Laser FibersGEX · Traditional	06/20/2014SE
K131229	Sparc System and Monarc, Monarc, and Monarc C SystemsOTN · Special	12/05/2013SE
K132655	Retroarc Retropubic Sling SystemOTN · Traditional	11/20/2013SE
K121805	Ams Large Pore Polyprophlene MeshOTO · Traditional	10/16/2012SE
K121641	Miniarc Pro Single-Incision Sling SystemPAH · Traditional	09/07/2012SE
K121612	Elevate Prolapse Repair Systems-Apical Needle Passer Sheath ModificationOTP · Special	07/20/2012SE
K120870	Greenlight Moxy Fiber OpticGEX · Special	06/15/2012SE
K112842	Ams Elevate PCOTP · Special	10/25/2011SE
K100746	Fiber OneGEX · Traditional	06/11/2010SE
K100807	Miniarc Precise Single-Incision Sling System Model: 720181, 720191PAH · Traditional	06/07/2010SE

Questions and answers

When was Ams Elevate PC Apical and Posterior ( and Anterior and Apical) Prolapse Repair System with Intepro Lite cleared by the FDA?

Ams Elevate PC Apical and Posterior ( and Anterior and Apical) Prolapse Repair System with Intepro Lite (K111118) received a 510(k) decision of Substantially Equivalent on July 1, 2011, 71 days after the submission was received.

What is the product code of K111118?

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.