Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
American Medical Systems, Inc. · Predicate Candidate Screening
72 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
70 daysmedian FDA review time
115 days90th percentile
72clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K132655 | RETROARC RETROPUBIC SLING SYSTEM | American Medical Systems, Inc. | 2013-11-20 | 86 | 0 |
| K112842 | AMS ELEVATE PC | American Medical Systems, Inc. | 2011-10-25 | 26 | 0 |
| K100807 | MINIARC PRECISE SINGLE-INCISION SLING SYSTEM MODEL: 720181, | American Medical Systems, Inc. | 2010-06-07 | 77 | 0 |
| K092735 | GREENLIGHT XPS LASER SYSTEM | American Medical Systems, Inc. | 2009-11-09 | 66 | 1 |
| K090934 | PFR SLING SYSTEM, PART OF THE AMS PELVIC FLOOR REPAIR SYSTEM | American Medical Systems, Inc. | 2009-06-02 | 61 | 0 |
| K090663 | AMS SPECTRA CONCEALABLE PENILE PROSTHESIS | American Medical Systems, Inc. | 2009-04-09 | 28 | 0 |
| K090713 | ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- | American Medical Systems, Inc. | 2009-04-02 | 15 | 0 |
| K082677 | AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH IN | American Medical Systems, Inc. | 2008-12-23 | 99 | 1 |
| K082730 | AMS ELEVATE APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM WITH | American Medical Systems, Inc. | 2008-11-26 | 69 | 0 |
| K082006 | AMS SPECTRA CONCEALABLE PENILE PROSTHESIS | American Medical Systems, Inc. | 2008-10-20 | 97 | 0 |
| K081613 | SPARC SYSTEM / MONARC, MONARC C, MONARC + SYSTEMS | American Medical Systems, Inc. | 2008-09-17 | 100 | 0 |
| K073219 | WMT COLLAGEN DERMAL MATRIX, 4 CM X 7 CM, MODEL 89XM-4X07, VM | American Medical Systems, Inc. | 2008-04-10 | 147 | 0 |
| K080185 | AMS ELEVATE WITH INTEPRO LITE PROLAPSE REPAIR SYSTEM, AMS EL | American Medical Systems, Inc. | 2008-04-10 | 76 | 0 |
| K073703 | AMS MINIARC SLING SYSTEM | American Medical Systems, Inc. | 2008-01-30 | 30 | 0 |
| K071902 | AMS MINIARC SLING SYSTEM | American Medical Systems, Inc. | 2007-08-24 | 45 | 0 |
| K070993 | TOPAS SYSTEM | American Medical Systems, Inc. | 2007-05-09 | 30 | 0 |
| K070065 | AMS SINGLE INCISION SLING SYSTEM (SIS-0) | American Medical Systems, Inc. | 2007-03-01 | 52 | 0 |
| K063713 | AMS SMART SLING SYSTEM | American Medical Systems, Inc. | 2007-02-22 | 70 | 0 |
| K053371 | AMS MALE TRANSOBTURATOR SLING SYSTEM | American Medical Systems, Inc. | 2006-02-03 | 60 | 3 |
| K051485 | AMS PELVIC FLOOR REPAIR SYSTEM | American Medical Systems, Inc. | 2005-08-03 | 58 | 0 |
| K051530 | MONARC + SUBFASCIAL HAMMOCK, MODEL 72404193; MONARC C SUBFAS | American Medical Systems, Inc. | 2005-07-08 | 29 | 1 |
| K050445 | AMS COLLAGEN DERMAL MATRIX | American Medical Systems, Inc. | 2005-06-17 | 115 | 1 |
| K042592 | INTEMESH SILICONE-COATED SLING AND SURGICAL MESH WITH INHIBI | American Medical Systems, Inc. | 2004-12-14 | 82 | 0 |
| K041948 | SPARC, MONARC, BIOARC SP AND BIOARC TO SLING SYSTEMS | American Medical Systems, Inc. | 2004-08-11 | 22 | 0 |
| K040623 | AMS PERIGEE SYSTEM | American Medical Systems, Inc. | 2004-05-17 | 69 | 0 |
| K040537 | AMS APOGEE VAULT SUSPENSION SYSTEM | American Medical Systems, Inc. | 2004-04-22 | 51 | 0 |
| K040521 | MODIFICATION TO AMS LARGE PORE POLYPROPYLENE MESH | American Medical Systems, Inc. | 2004-03-24 | 23 | 0 |
| K040538 | BIOARC SP SLING KIT AND BIOARC TO SLING KIT, MODELS 72403851 | American Medical Systems, Inc. | 2004-03-17 | 15 | 0 |
| K033636 | AMS LARGE PORE POLYPROPYLENE MESH | American Medical Systems, Inc. | 2003-12-31 | 42 | 0 |
| K030123 | BIOARC SP SLING KIT | American Medical Systems, Inc. | 2003-02-06 | 23 | 0 |
| K023516 | MONARC SLING SYSTEM | American Medical Systems, Inc. | 2002-11-19 | 29 | 1 |
| K021263 | MODIFICATION TO SPARC SLING SYSTEM | American Medical Systems, Inc. | 2002-05-15 | 23 | 0 |
| K020663 | MODIFICATION TO SPARC SLING SYSTEM | American Medical Systems, Inc. | 2002-03-28 | 27 | 0 |
| K020446 | MODIFICATION TO STRAIGHT-IN BONE SCREW FIXATION SYSTEM | American Medical Systems, Inc. | 2002-03-13 | 30 | 0 |
| K013355 | SPARC SLING SYSTEM | American Medical Systems, Inc. | 2001-10-26 | 16 | 0 |
| K012342 | AMS SOFT-TISSUE APPROXIMATION SYSTEM | American Medical Systems, Inc. | 2001-09-05 | 43 | 0 |
| K011251 | SPARC SLING SYSTEM | American Medical Systems, Inc. | 2001-08-01 | 99 | 0 |
| K011910 | IN-FAST BONE SCREW SYSTEM | American Medical Systems, Inc. | 2001-07-13 | 24 | 0 |
| K010990 | AMS SLING FIXATION SYSTEM | American Medical Systems, Inc. | 2001-06-22 | 80 | 0 |
| K010931 | AMS SACRAL COLPOPEXY SLING, MODEL 72403501 | American Medical Systems, Inc. | 2001-04-09 | 12 | 0 |
| K010277 | AMS FASCIAL-ANCHORING SYSTEM | American Medical Systems, Inc. | 2001-03-26 | 55 | 0 |
| K002721 | AMS TRIANGLE SILICONE-COATED SLING AND SURGICAL MESH | American Medical Systems, Inc. | 2000-11-29 | 90 | 0 |
| K000279 | STAPLETAC2 BONE ANCHOR SYSTEM | American Medical Systems, Inc. | 2000-03-01 | 30 | 0 |
| K991314 | COAGULOOP | American Medical Systems, Inc. | 1999-06-29 | 74 | 0 |
| K972091 | AMS FOREIGN BODY EXTRATOR | American Medical Systems, Inc. | 1997-08-29 | 86 | 0 |
| K971512 | AMS COAGULOOP RESECTION ELECTRODE | American Medical Systems, Inc. | 1997-07-24 | 87 | 0 |
| K971332 | AMS MAINSTAY UROLOGIC BONE ANCHOR | American Medical Systems, Inc. | 1997-07-09 | 90 | 0 |
| K963328 | AMS AMBICOR PENILE PROSTHESIS | American Medical Systems, Inc. | 1996-12-04 | 103 | 0 |
| K951716 | AMS 650 MALLERABLE PENIEL PROSTHESIS | American Medical Systems, Inc. | 1995-07-06 | 83 | 0 |
| K942578 | ENTRAC URETERAL BALLOON DILATATION CATHETERS | American Medical Systems, Inc. | 1994-08-19 | 80 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda