510(k) Report

510(k) · Cleared

Cleared

Ams Sacral Colpopexy Sling, Model 72403501

K010931510(k) SpecialCleared Apr 9, 200112-day reviewClass II21 CFR 878.3300

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

American Medical Systems, Inc. · OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed

Cleared on Apr 9, 2001 as substantially equivalent to K002721 (American Medical Systems, Inc., 2000) after a 12-day review. Its family tree reaches back 5 generations to 1993. 80 later devices descend from it.

Decided
Apr 9, 2001
Review
12 days
Class
Class II
Product code
OTO
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K931386 (1993). 9 ancestors in all, the oldest K922916 (1992). 80 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1998: 1 other ancestor1996: 2 other ancestors1992: 1 other ancestor2011: 6 descendants cleared2009: 8 descendants cleared2003: 1 descendant cleared2004: 3 descendants cleared2006: 4 descendants cleared2012: 12 descendants cleared2010: 3 descendants cleared2013: 6 descendants cleared2005: 2 descendants cleared2008: 11 descendants cleared2015: 2 descendants cleared2007: 1 descendant cleared2018: 3 descendants cleared2017: 1 descendant cleared2014: 1 descendant cleared2016: 2 descendants cleared2021: 1 descendant cleared2024: 2 descendants cleared2022: 2 descendants cleared2023: 3 descendants cleared2025: 3 descendants cleared2026: 3 descendants clearedK931386 · Hemashield Microvel/Woven Double Velour Fabric · Meadox Medicals, Div. Boston Scientific Corp. · 1993K963611 · Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft Patch,Vascutek Thin Wall Carotid Patch · Vascutek, Ltd. · 1996 · recalledK972651 · IN-Sling · Influence, Inc. · 1997K980482 · Triangle Sling · Influence, Inc. · 1998K002721 · Ams Triangle Silicone-Coated Sling and Surgical Mesh · American Medical Systems, Inc. · 20001990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 3 other ancestors4 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 10 descendants3 generations forward: 11 descendants4 generations forward: 18 descendants5 generations forward: 14 descendants6 generations forward: 10 descendants7 generations forward: 6 descendants8 generations forward: 6 descendants9 generations forward: 2 descendants K002721 · Ams Triangle Silicone-Coated Sling and Surgical Mesh · American Medical Systems, Inc. · 2000K980482 · Triangle Sling · Influence, Inc. · 1998K972651 · IN-Sling · Influence, Inc. · 1997K963611 · Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft Patch,Vascutek Thin Wall Carotid Patch · Vascutek, Ltd. · 1996 · recalledK931386 · Hemashield Microvel/Woven Double Velour Fabric · Meadox Medicals, Div. Boston Scientific Corp. · 1993−50+5
  1. Root · 5 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
  2. 4 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
  3. 3 generations backK972651 IN-SlingInfluence, Inc. · 1997
  4. 2 generations backK980482 Triangle SlingInfluence, Inc. · 1998
  5. 1 generation backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
  6. This deviceK010931 Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc. · 2001
  7. Descendant · cites it directly · 79 of its ownK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
  8. Descendant · 2 generations on · 74 of its ownK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
  9. Descendant · 2 generations on · 70 of its ownK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
  10. Descendant · 2 generations on · 70 of its ownK040537 Ams Apogee Vault Suspension SystemAmerican Medical Systems, Inc. · 2004
  11. Descendant · 3 generations on · 30 of its ownK050445 Ams Collagen Dermal MatrixAmerican Medical Systems, Inc. · 2005 · Recalled

Showing 5 of 80 descendants. See all descendants

Descendants cleared per year

2003: 12004: 32005: 22006: 42007: 12008: 112009: 82010: 32011: 62012: 122013: 62014: 12015: 22016: 22017: 12018: 32021: 12022: 22023: 32024: 22025: 32026: 3
2003high 12 (2012) · low 0 (2019)2026

Most influential descendants

Showing 5 of 80 · See all
  • K033636Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003 · cites it directly79descendants
  • K040521Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004 · 2 generations on74descendants
  • K040623Ams Perigee SystemAmerican Medical Systems, Inc. · 2004 · 2 generations on70descendants
  • K040537Ams Apogee Vault Suspension SystemAmerican Medical Systems, Inc. · 2004 · 2 generations on70descendants
  • K050445Ams Collagen Dermal MatrixAmerican Medical Systems, Inc. · 2005 · 3 generations on30descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K931386Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp.1993—
−4K963611Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft…Vascutek, Ltd.19961
−3K972651IN-SlingInfluence, Inc.1997—
−2K980482Triangle SlingInfluence, Inc.1998—
−1K002721Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc.2000—
0 (this device)K010931Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc.2001—
+1K033636Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc.2003—
+2K040521Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc.2004—
+2K040623Ams Perigee SystemAmerican Medical Systems, Inc.2004—
+2K040537Ams Apogee Vault Suspension SystemAmerican Medical Systems, Inc.2004—
+3K050445Ams Collagen Dermal MatrixAmerican Medical Systems, Inc.20051

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199620
199810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200430
200520
200640
200710
2008110
200980
201030
201160
2012120
201360
201410
201520
201620
201710
201830
202110
202220
202330
202420
202530
202630
FIG. 1 — Lineage of K010931, 1993–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in OTO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K002721Ams Triangle Silicone-Coated Sling and Surgical Mesh
Summary page 4
…Product Code: FTL Predicate Device: AMS Silicone-Coated Sling and Surgical Mesh K002721 Device Description The AMS SacralColpopexySlingisan alternate versionoftheAMS Silicone…
American Medical Systems, Inc.2000—

Also cleared against K002721: 3 other devices →

What descends from it? (80)

See all 80

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K033636Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc.200379
K092207Restorelle Polypropylene MeshMpathy Medical Devices, Inc.200913
K101722Alyte Y-Mesh GraftC.R. Bard, Inc.20118

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 8 years and passes through 4 companies; a new generation was cleared every 10 months on median.
  • 1 of the 9 ancestors has a recall of any class.
  • Of its descendants, K033636 (American Medical Systems, Inc., 2003) has gone furthest, with 79 descendants of its own.
  • 3 other devices also cite its predicate K002721.

How does its category compare?

All OTO devices

OTO Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · OTO

1in 2017

2009: 12011: 12012: 72013: 42014: 12015: 22017: 1
2007high 7 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OTO

95in 2013

2012: 101 days median2013: 95 days median
2007high 101 (2012) · low 95 (2013)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OTO

No recall names OTO since 2007.

Adverse event reports per year · OTO

79in 2025

2011: 72012: 1602013: 2,2722014: 2672015: 4482016: 1562017: 752018: 1452019: 3472020: 1532021: 2922022: 1122023: 1012024: 1132025: 79
2007high 2,272 (2013) · low 0 (2007)2025

MAUDE reports naming product code OTO, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20091—00
20100—00
20111—07
201271010160
201349502,272
20141—0267
20152—0448
20160—0156
20171—075
20180—0145
20190—0347
20200—0153
20210—0292
20220—0112
20230—0101
20240—0113
20250—079
20260—0—

What is it indicated for?

The AMS Silicone-Coated Sling and Surgical Mesh is an implant that is intended for the treatment of urinary incontinence resulting from urethral hypermobility or ISOD and for implantation to reinforce soft tissues where weakness exists in the urological, gynecological or gastroenterological anatomy. This includes, but is not limited to the following procedures: pubourethral support and bladder support, urethral and vaginal prolapse repair, colon and rectal prolapse repair, reconstruction of the pelvic floor and sacral-colposuspension.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K002721

3 other devices cite the same predicate.

  • K072974Surgimesh XBAspide Medical · 20082 recalls
  • K051485Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc. · 2005
  • K042592Intemesh Silicone-Coated Sling and Surgical Mesh with Inhibizone, Model 72403304American Medical Systems, Inc. · 2004

More from American Medical Systems, Inc.

75 FDA decisions under this applicant name. See the company

  • K132655Retroarc Retropubic Sling SystemAmerican Medical Systems, Inc. · 2013
  • K112842Ams Elevate PCAmerican Medical Systems, Inc. · 2011
  • K100807Miniarc Precise Single-Incision Sling System Model: 720181, 720191American Medical Systems, Inc. · 2010
  • K092735Greenlight XPS Laser SystemAmerican Medical Systems, Inc. · 20091 recall
  • K090934PFR Sling System, Part of the Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc. · 2009

Recent decisions in OTO

The OTO category page

  • K171271Polyform Synthetic MeshBoston Scientific Corporation · 2017
  • K150023Vertessa Lite Y-MeshCaldera Medical, Inc. · 2015
  • K150016Vertessa LiteCaldera Medical, Inc. · 2015
  • K140116Restorelle Y Contour MeshColoplast A/S · 2014
  • K132061Restorelle M, Restorelle XLColoplast Corp. · 2013

https://510kreport.com/device/K010931 · printed Nov 4, 2026

Cite this page

510(k) Report. “K010931: Ams Sacral Colpopexy Sling, Model 72403501.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K010931

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026