510(k) · Cleared
ClearedCleanCision Wound Retraction and Protection System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Prescient Surgical, Inc. · PQI Wound Retraction And Protection System
Cleared on Oct 25, 2017 as substantially equivalent to DEN150038 (Prescient Surgical, 2016) after a 103-day review. Its family tree reaches back 1 generation to 2016.
- Decided
- Oct 25, 2017
- Review
- 103 days
- Class
- Class II
- Product code
- PQI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN150038 (2016). No later device cites it as a predicate yet.
- Root · 1 generation backDEN150038 CleanCisionTM Wound Retraction and Protection SystemPrescient Surgical · 2016
- This deviceK172132 CleanCision Wound Retraction and Protection SystemPrescient Surgical, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN150038 | CleanCisionTM Wound Retraction and Protection System | Prescient Surgical | 2016 | — |
| 0 (this device) | K172132 | CleanCision Wound Retraction and Protection System | Prescient Surgical, Inc. | 2017 | — |
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 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
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 |
|---|---|---|---|
| * | DEN150038 | CleanCisionTM Wound Retraction and Protection SystemSummary page 4…Irrigating Wound Retractor Device Product Code: PQI Classification Panel: General and Plastic Surgery Predicate Device: DEN150038 - CleanCision™ Wound Retraction and Protection System DEVICE DESCRIPTION The CleanCision™ Wound R… | 2016 |
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?
- Its one ancestor has no recall.
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. 2017, 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?
The CleanCision™ Wound Retraction and Protection System is intended 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/K172132 · printed Nov 5, 2026
Cite this page
510(k) Report. “K172132: CleanCision Wound Retraction and Protection System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K172132
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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