De Novo · Granted
GrantedCleanCisionTM Wound Retraction and Protection System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prescient Surgical · PQI Wound Retraction And Protection System
Granted on Dec 16, 2016 as a new device type through De Novo after a 491-day review. 1 later device descends from it.
- Decided
- Dec 16, 2016
- Review
- 491 days
- Class
- Class II
- Product code
- PQI
- Recalls
- None
1 later device descends from it, 1 citing it directly.
- This deviceDEN150038 CleanCisionTM Wound Retraction and Protection SystemPrescient Surgical · 2016
- Descendant · cites it directly · 0 of its ownK172132 CleanCision Wound Retraction and Protection SystemPrescient Surgical, Inc. · 2017
Most influential descendants
Showing 1 of 1 · See all- K172132CleanCision Wound Retraction and Protection SystemPrescient Surgical, Inc. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | DEN150038 | CleanCisionTM Wound Retraction and Protection System | Prescient Surgical | 2016 | — |
| +1 | K172132 | CleanCision Wound Retraction and Protection System | Prescient Surgical, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
Sources: FDA De Novo 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 PQI? 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
Does it have a predicate?
De Novo decisions do not claim a predicate device.
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 |
|---|---|---|---|
| K172132 | CleanCision Wound Retraction and Protection System | 2017 | 0 |
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?
- Of its descendants, K172132 (Prescient Surgical, Inc., 2017) has gone furthest, with 0 descendants of its own.
How does its category compare?
All PQI devicesPQI Wound Retraction And Protection System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · PQI
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · PQI
Too few PQI 510(k)s in any year since 2007 to give a median.
Recalls per year · PQI
No recall names PQI since 2007.
Adverse event reports per year · PQI
No MAUDE report names PQI since 2007.
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 | 1 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Indicated for use by a surgeon during abdominal surgery to retract the surgical incision, provide access to the abdominal cavity, and irrigate the surgical wound edge. The device may aid in the prevention of wound edge contamination. This device is intended to deliver a sterile irrigant solution and serve as a conduit for fluid removal from the surgical wound edge.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN150038 · printed Nov 5, 2026
Cite this page
510(k) Report. “DEN150038: CleanCisionTM Wound Retraction and Protection System.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/DEN150038
Report an extraction error
Are you the manufacturer?
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