510(k) · Cleared
Recalled · Class II · 2024Capio SLIM Suture Capturing Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boston Scientific Corporation · PWI Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse
Cleared on Nov 3, 2017 as substantially equivalent to K122459 (Boston Scientific Corporation, 2012) after a 119-day review. Its family tree reaches back 14 generations to 1993. 1 later device descends from it. It has been recalled 4 times.
- Decided
- Nov 3, 2017
- Review
- 119 days
- Class
- Class II
- Product code
- PWI
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 14 generations to K931386 (1993). 40 ancestors in all, the oldest K905655 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 14 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 10 generations between
- 3 generations backK091131 Pelvic Floor Repair SystemBoston Scientific · 2009
- 2 generations backK103426 Lite Pelvic Floor Repair KitsBoston Scientific Corp · 2011
- 1 generation backK122459 Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal…Boston Scientific Corporation · 2012 · Recalled
- This deviceK172060 Capio SLIM Suture Capturing DeviceBoston Scientific Corporation · 2017
- Descendant · cites it directly · 0 of its ownK173527 Digitex Delivery DeviceColoplast A/S · 2018
Show all 14 generations
- Root · 14 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 13 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
- 12 generations backK972651 IN-SlingInfluence, Inc. · 1997
- 11 generations backK980482 Triangle SlingInfluence, Inc. · 1998
- 10 generations backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
- 9 generations backK010931 Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc. · 2001
- 8 generations backK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
- 7 generations backK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
- 6 generations backK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
- 5 generations backK071512 Gynecare Prolift +M* Pelvic Floor Repair SystemsETHICON, Inc. · 2008
- 4 generations backK081048 Pinnacle Pelvic Floor Repair Kit IIBoston Scientific Corp · 2008 · Recalled
- 3 generations backK091131 Pelvic Floor Repair SystemBoston Scientific · 2009
- 2 generations backK103426 Lite Pelvic Floor Repair KitsBoston Scientific Corp · 2011
- 1 generation backK122459 Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal…Boston Scientific Corporation · 2012 · Recalled
- This deviceK172060 Capio SLIM Suture Capturing DeviceBoston Scientific Corporation · 2017
Most influential descendants
Showing 1 of 1 · See all- K173527Digitex Delivery DeviceColoplast A/S · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K931386 | Hemashield Microvel/Woven Double Velour Fabric | Meadox Medicals, Div. Boston Scientific Corp. | 1993 | — |
| −13 | K963611 | Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft… | Vascutek, Ltd. | 1996 | 1 |
| −12 | K972651 | IN-Sling | Influence, Inc. | 1997 | — |
| −11 | K980482 | Triangle Sling | Influence, Inc. | 1998 | — |
| −10 | K002721 | Ams Triangle Silicone-Coated Sling and Surgical Mesh | American Medical Systems, Inc. | 2000 | — |
| −9 | K010931 | Ams Sacral Colpopexy Sling, Model 72403501 | American Medical Systems, Inc. | 2001 | — |
| −8 | K033636 | Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2003 | — |
| −7 | K040521 | Modification to Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2004 | — |
| −6 | K040623 | Ams Perigee System | American Medical Systems, Inc. | 2004 | — |
| −5 | K071512 | Gynecare Prolift +M* Pelvic Floor Repair Systems | ETHICON, Inc. | 2008 | — |
| −4 | K081048 | Pinnacle Pelvic Floor Repair Kit II | Boston Scientific Corp | 2008 | 1 |
| −3 | K091131 | Pelvic Floor Repair System | Boston Scientific | 2009 | — |
| −2 | K103426 | Lite Pelvic Floor Repair Kits | Boston Scientific Corp | 2011 | — |
| −1 | K122459 | Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal Support… | Boston Scientific Corporation | 2012 | 2 |
| 0 (this device) | K172060 | Capio SLIM Suture Capturing Device | Boston Scientific Corporation | 2017 | — |
| +1 | K173527 | Digitex Delivery Device | Coloplast A/S | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 2 | 0 |
| 1998 | 2 | 0 |
| 2000 | 1 | 0 |
| 2001 | 4 | 0 |
| 2002 | 5 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
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 PWI? 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
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K122459 | Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal Support SystemSummary page 5…l pelvic organ prolapse repair Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Classification: II Product Code: OTP Premarket Notification: K122459 F. Device Description The Capio™ SLIM Suture Capturing Device is urogynecologic mesh instrumentation used with urogynecol… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K173527 | Digitex Delivery Device | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 27, 2024 | Class II | Z-2452-2024 | Process change control | Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting in a prolonged procedure or additional medical intervention. |
| Jun 27, 2024 | Class II | Z-2451-2024 | Process change control | Some lots of Capio SLIM do not consistently catch the suture after activation possibly resulting in a prolonged procedure or additional medical intervention. |
| Feb 12, 2018 | Class II | Z-1616-2018 | Device Design | Potential for Capio sutures to break and /or detach. |
| Feb 12, 2018 | Class II | Z-1617-2018 | Device Design | Potential for Capio sutures to break and /or detach. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 24 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 8 of the 40 ancestors have a recall of any class.
- Of its descendants, K173527 (Coloplast A/S, 2018) has gone furthest, with 0 descendants of its own.
How does its category compare?
All PWI devicesPWI Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · PWI
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · PWI
Too few PWI 510(k)s in any year since 2007 to give a median.
Recalls per year · PWI
No recall names PWI since 2007.
Adverse event reports per year · PWI
88in 2025
MAUDE reports naming product code PWI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 4 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 0 | — | 0 | 6 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 75 |
| 2025 | 0 | — | 0 | 88 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Capio™ SLIM Suture Capturing Device is intended for use in general suturing applications during surgery to assist in the placement of suture material in tissues at the operative site. The Capio™ SLIM Suture Capturing Device is to be used with sensory and/or direct visual control.
The Capio SLIM Suture Capturing Device is also intended for use as an aid in the insertion, placement, fixation, or anchoring of surgical mesh during urogynecologic procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K172060 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172060: Capio SLIM Suture Capturing Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172060
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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