510(k) · Cleared
ClearedSurgisleeve Wound Protector
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Covidien · KKX Drape, Surgical, Antimicrobial
Cleared on Mar 12, 2014 as substantially equivalent to K041711 (Applied Medical Resources Corp., 2004) and 1 other predicate after a 61-day review. Its family tree reaches back 2 generations to 2004. 1 later device descends from it.
- Decided
- Mar 12, 2014
- Review
- 61 days
- Class
- Class II
- Product code
- KKX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K041711 (2004). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK041711 Alexis Wound Retractor, Models C8312, C8301, C8302, C8303, C8304Applied Medical Resources Corp. · 2004
- 1 generation backK120061 Wound ProtectorCovidien, Formerly US Surgical A Divison of Tyco H · 2012
- This deviceK140064 Surgisleeve Wound ProtectorCovidien · 2014
- Descendant · cites it directly · 0 of its ownK143091 Surgisleeve Wound ProtectorCovidien, LLC · 2014
Most influential descendants
Showing 1 of 1 · See all- K143091Surgisleeve Wound ProtectorCovidien, LLC · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K041711 | Alexis Wound Retractor, Models C8312, C8301, C8302, C8303, C8304 | Applied Medical Resources Corp. | 2004 | — |
| −1 | K120061 | Wound Protector | Covidien, Formerly US Surgical A Divison of Tyco H | 2012 | — |
| 0 (this device) | K140064 | Surgisleeve Wound Protector | Covidien | 2014 | — |
| +1 | K143091 | Surgisleeve Wound Protector | Covidien, LLC | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 KKX? 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 KKX device
- #1 K222578 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise…score 5.7 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K041711 | Alexis Wound Retractor, Models C8312, C8301, C8302, C8303, C8304Summary page 1…Surgical Drape and Drape Accessories per 21 CFR 878.4370 PREDICATE DEVICE(S): Applied Medical, Alexis TM Wound Retractors (K04171 1), Covidien Surgisleeve TM Wound Protector (K1 20061) DEVICE DESCRIPTION:… | 2004 |
| * | K120061 | Wound ProtectorSummary page 1…DEVICE(S): Applied Medical, Alexis TM Wound Retractors (K04171 1), Covidien Surgisleeve TM Wound Protector (K1 20061) DEVICE DESCRIPTION: Wound retraction device providing abdominal access and… | 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 |
|---|---|---|---|
| K143091 | Surgisleeve Wound Protector | 2014 | 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?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 7.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K143091 (Covidien, LLC, 2014) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K041711.
How does its category compare?
All KKX devicesKKX Drape, Surgical, Antimicrobial: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · KKX
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · KKX
182in 2014
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KKX
2in 2024
Class I (7 since 2007) Class II/III not classified
Adverse event reports per year · KKX
24in 2025
MAUDE reports naming product code KKX, 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 | 4 | 181 | 1 | 24 |
| 2008 | 5 | 164 | 0 | 24 |
| 2009 | 5 | 114 | 0 | 27 |
| 2010 | 8 | 107 | 1 | 25 |
| 2011 | 4 | 147 | 1 | 57 |
| 2012 | 2 | — | 1 | 40 |
| 2013 | 3 | 227 | 7 | 63 |
| 2014 | 6 | 182 | 7 (7) | 28 |
| 2015 | 2 | — | 0 | 33 |
| 2016 | 0 | — | 4 | 56 |
| 2017 | 1 | — | 0 | 30 |
| 2018 | 0 | — | 0 | 32 |
| 2019 | 0 | — | 0 | 41 |
| 2020 | 1 | — | 0 | 16 |
| 2021 | 1 | — | 0 | 41 |
| 2022 | 0 | — | 0 | 19 |
| 2023 | 2 | — | 0 | 32 |
| 2024 | 0 | — | 2 | 19 |
| 2025 | 0 | — | 0 | 24 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
The Surgisleeve™ Wound Protector is indicated for use to access the abdominal cavity during surgery through an atraumatically retracted incision, deliver maximum exposure of the abdominal cavity with minimum incision size, and protect against wound contamination during laparoscopic and open surgery. Additionally, the small size Wound Protector is indicated for use to access the thoracic cavity during cardiac and general surgical procedures through an…
Read the full statement (97 words)
The Surgisleeve™ Wound Protector is indicated for use to access the abdominal cavity during surgery through an atraumatically retracted incision, deliver maximum exposure of the abdominal cavity with minimum incision size, and protect against wound contamination during laparoscopic and open surgery. Additionally, the small size Wound Protector is indicated for use to access the thoracic cavity during cardiac and general surgical procedures through an atraumatically retracted incision. The extra-small Wound Protector is also indicated for use to access the thoracic cavity and other soft tissue retraction during cardiac and general surgical procedures through an atraumnatically retracted incision.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140064 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140064: Surgisleeve Wound Protector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140064
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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