510(k) Report

510(k) · Cleared

Cleared

Ams Single Incision Sling System (Sis-0)

K070065510(k) SpecialCleared Mar 1, 200752-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. · PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling

Cleared on Mar 1, 2007 as substantially equivalent to K023516 (American Medical Systems, Inc., 2002) after a 52-day review. Its family tree reaches back 5 generations to 2001. 17 later devices descend from it.

Decided
Mar 1, 2007
Review
52 days
Class
Class II
Product code
PAH
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K011251 (2001). 17 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2007: 1 descendant cleared2010: 2 descendants cleared2008: 2 descendants cleared2012: 3 descendants cleared2009: 3 descendants cleared2011: 3 descendants cleared2017: 1 descendant cleared2023: 1 descendant cleared2024: 1 descendant cleared×2: 2 generations cleared close together, K011251 (2001), K013355 (2001) ×2: 2 generations cleared close together, K020663 (2002), K021263 (2002) K023516 · Monarc Sling System · American Medical Systems, Inc. · 2002 · recalled200020052010201520202025
Descendants, by generation 1 generation forward: 2 descendants2 generations forward: 3 descendants3 generations forward: 4 descendants4 generations forward: 5 descendants5 generations forward: 3 descendants K023516 · Monarc Sling System · American Medical Systems, Inc. · 2002 · recalledK021263 · Modification to Sparc Sling System · American Medical Systems, Inc. · 2002K020663 · Modification to Sparc Sling System · American Medical Systems, Inc. · 2002K013355 · Sparc Sling System · American Medical Systems, Inc. · 2001K011251 · Sparc Sling System · American Medical Systems, Inc. · 2001−50+5
  1. Root · 5 generations backK011251 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
  2. 4 generations backK013355 Sparc Sling SystemAmerican Medical Systems, Inc. · 2001
  3. 3 generations backK020663 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
  4. 2 generations backK021263 Modification to Sparc Sling SystemAmerican Medical Systems, Inc. · 2002
  5. 1 generation backK023516 Monarc Sling SystemAmerican Medical Systems, Inc. · 2002 · Recalled
  6. This deviceK070065 Ams Single Incision Sling System (Sis-0)American Medical Systems, Inc. · 2007
  7. Descendant · cites it directly · 16 of its ownK071902 Ams Miniarc Sling SystemAmerican Medical Systems, Inc. · 2007
  8. Descendant · 2 generations on · 15 of its ownK073703 Ams Miniarc Sling SystemAmerican Medical Systems, Inc. · 2008
  9. Descendant · 3 generations on · 5 of its ownK081275 Boston Scientific Surgical MeshBoston Scientific Corp · 2008
  10. Descendant · 4 generations on · 3 of its ownK083471 GMD Universal Sling, Model Product Code 1010 and 1020Generic Medical Device, Inc. · 2009 · Recalled
  11. Descendant · 3 generations on · 2 of its ownK121562 Altis Single Incision Cling SystemColoplast A/S · 2012

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2007: 12008: 22009: 32010: 22011: 32012: 32017: 12023: 12024: 1
2007high 3 (2009) · low 0 (2013)2026

Most influential descendants

Showing 5 of 17 · See all
  • K071902Ams Miniarc Sling SystemAmerican Medical Systems, Inc. · 2007 · cites it directly16descendants
  • K073703Ams Miniarc Sling SystemAmerican Medical Systems, Inc. · 2008 · 2 generations on15descendants
  • K081275Boston Scientific Surgical MeshBoston Scientific Corp · 2008 · 3 generations on5descendants
  • K083471GMD Universal Sling, Model Product Code 1010 and 1020Generic Medical Device, Inc. · 2009 · 4 generations on3descendants
  • K121562Altis Single Incision Cling SystemColoplast A/S · 2012 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K011251Sparc Sling SystemAmerican Medical Systems, Inc.2001—
−4K013355Sparc Sling SystemAmerican Medical Systems, Inc.2001—
−3K020663Modification to Sparc Sling SystemAmerican Medical Systems, Inc.2002—
−2K021263Modification to Sparc Sling SystemAmerican Medical Systems, Inc.2002—
−1K023516Monarc Sling SystemAmerican Medical Systems, Inc.20021
0 (this device)K070065Ams Single Incision Sling System (Sis-0)American Medical Systems, Inc.2007—
+1K071902Ams Miniarc Sling SystemAmerican Medical Systems, Inc.2007—
+2K073703Ams Miniarc Sling SystemAmerican Medical Systems, Inc.2008—
+3K081275Boston Scientific Surgical MeshBoston Scientific Corp2008—
+4K083471GMD Universal Sling, Model Product Code 1010 and 1020Generic Medical Device, Inc.20092
+3K121562Altis Single Incision Cling SystemColoplast A/S2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200710
200820
200930
201020
201130
201230
201710
202310
202410
FIG. 1 — Lineage of K070065, 2001–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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

Top candidate predicates for a new PAH device

  1. #1 K242473 Altis Single Incision Sling System (519650)…score 10.9 · 10 generations · no Class I recall
  2. #2 Held for the reportin 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
*K023516Monarc Sling System
Summary page 1
…urgical Mesh Device Trade Name: AMS Single Incision Sling System Device Classification Name: Surgical Mesh, polymeric (PAH) Predicate Device: Monarc™ subfascial hammock (K023516), Device Description The AMS Single Incision Sling System is a modification of Monarc consisting of a sling and a surgical inst…
American Medical Systems, Inc.20021

Also cleared against K023516: 9 other devices →

What descends from it? (17)

See all 17

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

NumberDeviceApplicantDecidedDescendants
K071902Ams Miniarc Sling SystemAmerican Medical Systems, Inc.200716
K100807Miniarc Precise Single-Incision Sling System Model: 720181, 720191American Medical Systems, Inc.20102

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 6 years and passes through 1 company; a new generation was cleared every 5 months on median.
  • 1 of the 5 ancestors has a recall of any class.
  • Of its descendants, K071902 (American Medical Systems, Inc., 2007) has gone furthest, with 16 descendants of its own.
  • 9 other devices also cite its predicate K023516.

How does its category compare?

All PAH devices

PAH Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · PAH

1in 2024

2007: 22008: 32009: 22010: 12011: 12012: 42020: 12023: 12024: 1
2007high 4 (2012) · low 0 (2013)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · PAH

128in 2012

2008: 61 days median2012: 128 days median
2007high 128 (2012) · low 61 (2008)2026

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

Recalls per year · PAH

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · PAH

242in 2025

2010: 12011: 72012: 1292013: 2,3862014: 3382015: 2752016: 6972017: 1272018: 1742019: 2982020: 1712021: 3182022: 1592023: 1542024: 2872025: 242
2007high 2,386 (2013) · low 0 (2007)2025

MAUDE reports naming product code PAH, 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
20072—00
200836100
20092—00
20101—01
20111—07
201241280129
20130—02,386
20140—0338
20150—1275
20160—0697
20170—0127
20180—0174
20190—0298
20201—0171
20210—0318
20220—0159
20231—0154
20241—0287
20250—0242
20260—0—

What is it indicated for?

The Single Incision Sling System is intended for the placement of a suburethral sling for the treatment of female stress urinary incontinence (SUT) resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

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 K023516

9 other devices cite the same predicate.

  • K063713Ams Smart Sling SystemAmerican Medical Systems, Inc. · 2007
  • K053371Ams Male Transobturator Sling SystemAmerican Medical Systems, Inc. · 20063 recalls
  • K051533I-STOPCl Medical · 2005
  • K051485Ams Pelvic Floor Repair SystemAmerican Medical Systems, Inc. · 2005
  • K051530Monarc + Subfascial Hammock, Model 72404193; Monarc C Subfascial Hammock, Model 72404195.American Medical Systems, Inc. · 20051 recall
  • K041948Sparc, Monarc, Bioarc SP and Bioarc to Sling SystemsAmerican 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 PAH

The PAH category page

  • K242473Altis Single Incision Sling System (519650); Aris Transobturator Sling System (519551); Supris Retropubic…Coloplast Corp. · 2024
  • K221874Altis Single Incision Sling SystemColoplast A/S · 2023
  • K191416Desara One Single Incision Sling System, 1 Pack ; Desara One Single Incision Sling System, 3 PackCaldera Medical, Inc. · 2020
  • K121562Altis Single Incision Cling SystemColoplast A/S · 2012
  • K123179Ajust Helical Adjustable Single-Incision SlingC.R. Bard, Inc. · 2012

https://510kreport.com/device/K070065 · printed Nov 6, 2026

Cite this page

510(k) Report. “K070065: Ams Single Incision Sling System (Sis-0).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070065

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026