510(k) · Cleared
ClearedDigitex Delivery Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Coloplast A/S · PWI Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse
Cleared on Feb 12, 2018 as substantially equivalent to K172060 (Boston Scientific Corporation, 2017) after a 90-day review. Its family tree reaches back 15 generations to 1993.
- Decided
- Feb 12, 2018
- Review
- 90 days
- Class
- Class II
- Product code
- PWI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K931386 (1993). 41 ancestors in all, the oldest K905655 (1990). No later device cites it as a predicate yet.
- Root · 15 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 11 generations between
- 3 generations backK103426 Lite Pelvic Floor Repair KitsBoston Scientific Corp · 2011
- 2 generations backK122459 Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal…Boston Scientific Corporation · 2012 · Recalled
- 1 generation backK172060 Capio SLIM Suture Capturing DeviceBoston Scientific Corporation · 2017 · Recalled
- This deviceK173527 Digitex Delivery DeviceColoplast A/S · 2018
Show all 15 generations
- Root · 15 generations backK931386 Hemashield Microvel/Woven Double Velour FabricMeadox Medicals, Div. Boston Scientific Corp. · 1993
- 14 generations backK963611 Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek…Vascutek, Ltd. · 1996 · Recalled
- 13 generations backK972651 IN-SlingInfluence, Inc. · 1997
- 12 generations backK980482 Triangle SlingInfluence, Inc. · 1998
- 11 generations backK002721 Ams Triangle Silicone-Coated Sling and Surgical MeshAmerican Medical Systems, Inc. · 2000
- 10 generations backK010931 Ams Sacral Colpopexy Sling, Model 72403501American Medical Systems, Inc. · 2001
- 9 generations backK033636 Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2003
- 8 generations backK040521 Modification to Ams Large Pore Polypropylene MeshAmerican Medical Systems, Inc. · 2004
- 7 generations backK040623 Ams Perigee SystemAmerican Medical Systems, Inc. · 2004
- 6 generations backK071512 Gynecare Prolift +M* Pelvic Floor Repair SystemsETHICON, Inc. · 2008
- 5 generations backK081048 Pinnacle Pelvic Floor Repair Kit IIBoston Scientific Corp · 2008 · Recalled
- 4 generations backK091131 Pelvic Floor Repair SystemBoston Scientific · 2009
- 3 generations backK103426 Lite Pelvic Floor Repair KitsBoston Scientific Corp · 2011
- 2 generations backK122459 Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal…Boston Scientific Corporation · 2012 · Recalled
- 1 generation backK172060 Capio SLIM Suture Capturing DeviceBoston Scientific Corporation · 2017 · Recalled
- This deviceK173527 Digitex Delivery DeviceColoplast A/S · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K931386 | Hemashield Microvel/Woven Double Velour Fabric | Meadox Medicals, Div. Boston Scientific Corp. | 1993 | — |
| −14 | K963611 | Vascutek Cardiovascular Fabric: Vascutek Gelseal Patch,Vascutek Gelsoft… | Vascutek, Ltd. | 1996 | 1 |
| −13 | K972651 | IN-Sling | Influence, Inc. | 1997 | — |
| −12 | K980482 | Triangle Sling | Influence, Inc. | 1998 | — |
| −11 | K002721 | Ams Triangle Silicone-Coated Sling and Surgical Mesh | American Medical Systems, Inc. | 2000 | — |
| −10 | K010931 | Ams Sacral Colpopexy Sling, Model 72403501 | American Medical Systems, Inc. | 2001 | — |
| −9 | K033636 | Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2003 | — |
| −8 | K040521 | Modification to Ams Large Pore Polypropylene Mesh | American Medical Systems, Inc. | 2004 | — |
| −7 | K040623 | Ams Perigee System | American Medical Systems, Inc. | 2004 | — |
| −6 | K071512 | Gynecare Prolift +M* Pelvic Floor Repair Systems | ETHICON, Inc. | 2008 | — |
| −5 | K081048 | Pinnacle Pelvic Floor Repair Kit II | Boston Scientific Corp | 2008 | 1 |
| −4 | K091131 | Pelvic Floor Repair System | Boston Scientific | 2009 | — |
| −3 | K103426 | Lite Pelvic Floor Repair Kits | Boston Scientific Corp | 2011 | — |
| −2 | K122459 | Pinnacle Lite Pelvic Floor Repair Kit, Posterior Uphold Lite Vaginal Support… | Boston Scientific Corporation | 2012 | 2 |
| −1 | K172060 | Capio SLIM Suture Capturing Device | Boston Scientific Corporation | 2017 | 4 |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K172060 | Capio SLIM Suture Capturing DeviceSummary page 4…performance, indication, design and materials to the Capio SLIM Suture Capturing Device, cleared under K172060 on November 3, 2017. The predicate device has not be… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 9 companies; a new generation was cleared every 10 months on median.
- 9 of the 41 ancestors have a recall of any class.
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. 2018, 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 Digitex Delivery Device is a single-use device intended for use as an aid in suturing during transvaginal pelvic organ prolapse procedures with surgical mesh.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K173527 · printed Nov 6, 2026
Cite this page
510(k) Report. “K173527: Digitex Delivery Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173527
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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