Company ยท US
American Medical Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1979 to 2014. Name variants (Inc, Corp, punctuation) are merged.
82510(k) clearances (0 in 12 months)
24recalls (0 in 12 months)
10recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| OTN | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator | 15 |
| FAE | Prosthesis, Penile | 13 |
| OTP | Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed | 13 |
| JCW | Prosthesis, Penis, Inflatable | 9 |
| FTL | Mesh, Surgical, Polymeric | 7 |
| PAH | Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling | 5 |
| GEX | Powered Laser Surgical Instrument | 4 |
| KOE | Dilator, Urethral | 4 |
| EZN | Dilator, Catheter, Ureteral | 3 |
| EZY | Device, Incontinence, Mechanical/Hydraulic | 3 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 3 |
| OTO | Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed | 3 |
| FAG | Prosthesis, Urethral Sphincter | 2 |
| FAS | Electrode, Electrosurgical, Active, Urological | 2 |
| FTM | Mesh, Surgical | 2 |
| HWC | Screw, Fixation, Bone | 2 |
| OTM | Mesh, Surgical, For Stress Urinary Incontinence, Male | 2 |
| DWJ | System, Thermal Regulating | 1 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 |
| FAD | Stent, Ureteral | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 20, 2014 | K140679 | SUREFLEX LITHOTRIPSY LASER FIBERS American Medical Systems | GEX |
| Dec 5, 2013 | K131229 | SPARC SYSTEM AND MONARC, MONARC, AND MONARC C SYSTEMS American Medical Systems | OTN |
| Nov 20, 2013 | K132655 | RETROARC RETROPUBIC SLING SYSTEM American Medical Systems, Inc. | OTN |
| Oct 16, 2012 | K121805 | AMS LARGE PORE POLYPROPHLENE MESH American Medical Systems | OTO |
| Sep 7, 2012 | K121641 | MINIARC PRO SINGLE-INCISION SLING SYSTEM American Medical Systems | PAH |
| Jul 20, 2012 | K121612 | ELEVATE PROLAPSE REPAIR SYSTEMS-APICAL NEEDLE PASSER SHEATH MODIFICATION American Medical Systems | OTP |
| Jun 15, 2012 | K120870 | GREENLIGHT MOXY FIBER OPTIC American Medical Systems | GEX |
| Oct 25, 2011 | K112842 | AMS ELEVATE PC American Medical Systems, Inc. | OTP |
| Jul 1, 2011 | K111118 | AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE American Medical Systems | OTP |
| Jun 11, 2010 | K100746 | FIBER ONE American Medical Systems | GEX |
| Jun 7, 2010 | K100807 | MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, 720191 American Medical Systems, Inc. | PAH |
| Nov 9, 2009 | K092735 | GREENLIGHT XPS LASER SYSTEM American Medical Systems, Inc. | GEX |
| Jun 2, 2009 | K090934 | PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM American Medical Systems, Inc. | FTL |
| Apr 9, 2009 | K090663 | AMS SPECTRA CONCEALABLE PENILE PROSTHESIS American Medical Systems, Inc. | FAE |
| Apr 2, 2009 | K090713 | ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP American Medical Systems, Inc. | OTP |
| Dec 23, 2008 | K082677 | AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE American Medical Systems, Inc. | OTP |
| Dec 4, 2008 | K082387 | APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, PART OF THE AMS; PELVIC FLOOR REPAIR SYSTEM American Medical Systems | OTP |
| Nov 26, 2008 | K082730 | AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE, AMS ELEVATE APICAL AND POSTERIOR PROLAPSE American Medical Systems, Inc. | OTP |
| Oct 20, 2008 | K082006 | AMS SPECTRA CONCEALABLE PENILE PROSTHESIS American Medical Systems, Inc. | FAE |
| Oct 15, 2008 | K081710 | APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE American Medical Systems | OTP |
| Sep 17, 2008 | K081613 | SPARC SYSTEM / MONARC, MONARC C, MONARC + SYSTEMS American Medical Systems, Inc. | OTN |
| Apr 10, 2008 | K080185 | AMS ELEVATE WITH INTEPRO LITE PROLAPSE REPAIR SYSTEM, AMS ELEVATE WITH INTEXEN LP PROLAPSE REPAIR SYSTEM American Medical Systems, Inc. | OTP |
| Apr 10, 2008 | K073219 | WMT COLLAGEN DERMAL MATRIX, 4 CM X 7 CM, MODEL 89XM-4X07, VMT COLLAGEN DERMAL MATRIX, 6 CM X 8 CM, MODEL 89XM-6X08 American Medical Systems, Inc. | FTM |
| Jan 30, 2008 | K073703 | AMS MINIARC SLING SYSTEM American Medical Systems, Inc. | PAH |
| Aug 24, 2007 | K071902 | AMS MINIARC SLING SYSTEM American Medical Systems, Inc. | PAH |
| May 9, 2007 | K070993 | TOPAS SYSTEM American Medical Systems, Inc. | FTL |
| Mar 1, 2007 | K070065 | AMS SINGLE INCISION SLING SYSTEM (SIS-0) American Medical Systems, Inc. | PAH |
| Feb 22, 2007 | K063713 | AMS SMART SLING SYSTEM American Medical Systems, Inc. | OTN |
| Feb 3, 2006 | K053371 | AMS MALE TRANSOBTURATOR SLING SYSTEM American Medical Systems, Inc. | OTM |
| Aug 3, 2005 | K051485 | AMS PELVIC FLOOR REPAIR SYSTEM American Medical Systems, Inc. | OTO |
| Jul 8, 2005 | K051530 | MONARC + SUBFASCIAL HAMMOCK, MODEL 72404193; MONARC C SUBFASCIAL HAMMOCK, MODEL 72404195. American Medical Systems, Inc. | OTN |
| Jun 17, 2005 | K050445 | AMS COLLAGEN DERMAL MATRIX American Medical Systems, Inc. | PAG |
| Dec 14, 2004 | K042592 | INTEMESH SILICONE-COATED SLING AND SURGICAL MESH WITH INHIBIZONE, MODEL 72403304 American Medical Systems, Inc. | OTN |
| Aug 11, 2004 | K041948 | SPARC, MONARC, BIOARC SP AND BIOARC TO SLING SYSTEMS American Medical Systems, Inc. | OTN |
| May 17, 2004 | K040623 | AMS PERIGEE SYSTEM American Medical Systems, Inc. | OTP |
| Apr 22, 2004 | K040537 | AMS APOGEE VAULT SUSPENSION SYSTEM American Medical Systems, Inc. | OTP |
| Mar 24, 2004 | K040521 | MODIFICATION TO AMS LARGE PORE POLYPROPYLENE MESH American Medical Systems, Inc. | OTP |
| Mar 17, 2004 | K040538 | BIOARC SP SLING KIT AND BIOARC TO SLING KIT, MODELS 72403851, 72403996 American Medical Systems, Inc. | OTN |
| Dec 31, 2003 | K033636 | AMS LARGE PORE POLYPROPYLENE MESH American Medical Systems, Inc. | OTP |
| Feb 6, 2003 | K030123 | BIOARC SP SLING KIT American Medical Systems, Inc. | OTN |
| Nov 19, 2002 | K023516 | MONARC SLING SYSTEM American Medical Systems, Inc. | OTN |
| May 15, 2002 | K021263 | MODIFICATION TO SPARC SLING SYSTEM American Medical Systems, Inc. | OTN |
| Mar 28, 2002 | K020663 | MODIFICATION TO SPARC SLING SYSTEM American Medical Systems, Inc. | OTN |
| Mar 13, 2002 | K020446 | MODIFICATION TO STRAIGHT-IN BONE SCREW FIXATION SYSTEM American Medical Systems, Inc. | HWC |
| Oct 26, 2001 | K013355 | SPARC SLING SYSTEM American Medical Systems, Inc. | OTN |
| Sep 5, 2001 | K012342 | AMS SOFT-TISSUE APPROXIMATION SYSTEM American Medical Systems, Inc. | FZP |
| Aug 1, 2001 | K011251 | SPARC SLING SYSTEM American Medical Systems, Inc. | OTN |
| Jul 13, 2001 | K011910 | IN-FAST BONE SCREW SYSTEM American Medical Systems, Inc. | HWC |
| Jun 22, 2001 | K010990 | AMS SLING FIXATION SYSTEM American Medical Systems, Inc. | GAW |
| Apr 9, 2001 | K010931 | AMS SACRAL COLPOPEXY SLING, MODEL 72403501 American Medical Systems, Inc. | OTO |
Newest 50 of 82.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 16, 2014 | American Medical Systems, Inc. AdVance"Male Sling System, REF 720088-01 &
AdVance" XP Male Sling System REF 720163-01
(not commercially available in the US)
The AdVance Male Sling System consists of two, sterile single-use surgic Terminated |
OTM | K053371 |
| Dec 16, 2014 | American Medical Systems, Inc. AMS Monarc + Subfascial Hammock with Tensioning Suture REF 72404193 and AMS Monarc C Subfascial Hammock with Tensioning Suture REF 72404195, Sterilized Using Ethylene Oxide.
The Monarc + and Monarc C Terminated |
OTN | K051530 K131229 |
| Nov 13, 2014 | American Medical Systems, Inc. AMS 700 Series Inflatable Penile Prosthesis Accessory Kit (AMS 700 Line Accessory Kit), 72401850.
Keith Needles are part of the AMS 700 Accessory Kit. In conjunction with the Furlow Insertion Tool (F Terminated |
JCW | None listed |
| May 10, 2013 | American Medical Systems, Inc. AMS 800 Urinary Control System.
The AMS 800 Urinary Control System is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery. Terminated |
EZY | None listed |
| May 10, 2013 | American Medical Systems, Inc. AMS 800 Urinary Control System.
The AMS 800 Urinary Control System is used to treat urinary incontinence due to reduced outlet resistance (intrinsic sphincter deficiency) following prostate surgery Terminated |
EZY | None listed |
| Nov 7, 2012 | American Medical Systems, Inc. AMS AdVance" Male Sling System
720088-01 AMS AdVance" Male Sling System (US)
720088-02 AMS AdVance" Male Sling System (Intl)
72404224 AMS Male TO Sling System (Intl).
The AMS AdVance Male Sling Syste Terminated |
FTL | K053371 |
| Jul 7, 2011 | American Medical Systems, Inc. Elevate System with IntePro Lite", Anterior and Apical Prolapse Repair System, REF720093-01, Sterile EO, Manufactured by:American Medical Systems, Inc., 10700 Bren Road West, Minnetonka, MN 55343 USA
Terminated |
FTL | K082677 |
| Jun 27, 2011 | American Medical Systems, Inc. AMS 800 Urinary Control System Control Pump, REF 72400098, (720172-01 Japan only ), Sterilization Method Steam, American Medical systems Inc., 10700 Bren Road West, Minnetonka, MN 55343
InhibiZone Terminated |
EZY | None listed |
| Jun 27, 2011 | American Medical Systems, Inc. AMS Acticon Neosphincter Pump, Product Number 72402287, Sterilization Method Steam, American Medical systems Inc., 10700 Bren Road West, Minnetonka, MN 55343.
The Acticon Neosphincter is an implanta Terminated |
MIP | None listed |
| Dec 27, 2010 | American Medical Systems, Inc. Model # 720088-01: AMS AdVance Male Sling System, US; Model # 720088-02: AMS AdVance Male Sling System, INTL; Model # 72404224: Male TO Sling System, INTL.
Sterilization Method ETO, American Medical Terminated |
FTL | K053371 |
| Jan 27, 2009 | American Medical Systems AMS InteXen LP Collagen Dermal Matrix, REF 72404066. Product Size: 8 x 12 cm. AMS InteXen LP is a sterile non-perforated processed porcine collagen dermal matrix. Sterile EO. American Medical Terminated |
FTM | K050445 |
| Sep 20, 2008 | American Medical Systems AMS 700 CX MS Pump IZ, Preconnect Penoscrotal, 18 cm, Sterile EO, REF 72404232, Lot 551668001. Expiration Date 2010-Jun-20, Manufacture Date 2008 Jun 20. Terminated |
JCW | None listed |
| Jul 16, 2008 | American Medical Systems AMS In-Fast Ultra Kit with Polypropylene Suture, REF 72403885. Sterile Transvaginal Bladder Neck Support System. Terminated |
MBI | K970292 |
| May 9, 2007 | American Medical Systems AMS 700 LGX MS Pump IZ Preconnected penile Prosthesis with InhibiZone, product length 15 cm, product number 72404251. Penoscrotal Approach - with InhibiZone, 1 MS Pump, 2 Cylinders. Terminated |
JCW | None listed |
| May 9, 2007 | American Medical Systems AMS 700 CX MS Pump IZ Preconnected penile Prosthesis with InhibiZone, product length 15 cm product number 72404231. Penoscrotal Approach - with InhibiZone, 1 Pump, 2 Cylinders. Terminated |
JCW | None listed |
| May 9, 2007 | American Medical Systems AMS 700 CX Preconnected penile Prosthesis with InhibiZone, product length 18 cm, product number 72402987. Penoscrotal Approach - with InhibiZone, 8 Extenders, one pair each .5cm, 1cm, 2cm 3cm; 1 Pump Terminated |
JCW | None listed |
| May 9, 2007 | American Medical Systems AMS 700 CX MS Pump IZ Preconnected penile Prosthesis, product length 18 cm, product number 72404232. Penoscrotal Approach - with InhibiZone, 1 MS Pump, 2 Cylinders. Terminated |
JCW | None listed |
| May 9, 2007 | American Medical Systems AMS 700 Ultrex Preconnected penile Prosthesis with InhibiZone, Product length 18 cm, product number 72403924. Penoscrotal Approach - with InhibiZone, 8 Extenders, one pair each .5cm, 1cm, 2cm 3cm; 1 Terminated |
JCW | None listed |
| Apr 3, 2007 | American Medical Systems AMS DURA-II Universal Tips, 2cm, Product Number 72009361, Sterile, American Medical Systems, Inc. Minnetonka, MN Terminated |
FAE | K953640 |
| Apr 3, 2007 | American Medical Systems AMS DURA-II Distal Tips, 4 cm, Product Number 72009340, Sterile, American Medical Systems, Inc. Minnetonka, MN Terminated |
FAE | K953640 |
| Mar 23, 2006 | American Medical Systems her option Cryoablation Therapy Disposable Probe, Model CU-1. Sterile. Manufactured at: American Medical Systems, Inc., 10700 Bren Road West, Minnetonka, MN 55343 USA. The Her Option Cryoablation Terminated |
MNB | None listed |
| Jul 20, 2004 | American Medical Systems Monarc Subfascial Hammock With Tensioning Suture, Product Number 72403830/1 Terminated |
FTL | K023516 |
| Apr 29, 2004 | American Medical Systems AMS Ambicor Penile Prosthesis, Penoscrotal Approach, Length: 16 cm, Diameter: 11 mm, Product Number 72401451 Terminated |
JCW | None listed |
| Apr 29, 2004 | American Medical Systems AMS Ambicor Penile Prosthesis, Penoscrotal Approach, Length: 14 cm, Diameter: 11 mm, Product Number 72401450 Terminated |
JCW | None listed |