510(k) · Cleared
ClearedAlexis Laparoscopic System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Applied Medical Resources Corp. · KGW Ring (Wound Protector), Drape Retention, Internal
Cleared on Nov 5, 2009 as substantially equivalent to K041711 (Applied Medical Resources Corp., 2004) after a 15-day review. Its family tree reaches back 1 generation to 2004.
- Decided
- Nov 5, 2009
- Review
- 15 days
- Class
- Class II
- Product code
- KGW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K041711 (2004). No later device cites it as a predicate yet.
- Root · 1 generation backK041711 Alexis Wound Retractor, Models C8312, C8301, C8302, C8303, C8304Applied Medical Resources Corp. · 2004
- This deviceK093296 Alexis Laparoscopic SystemApplied Medical Resources Corp. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K041711 | Alexis Wound Retractor, Models C8312, C8301, C8302, C8303, C8304 | Applied Medical Resources Corp. | 2004 | — |
| 0 (this device) | K093296 | Alexis Laparoscopic System | Applied Medical Resources Corp. | 2009 | — |
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 KGW? 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 KGW device
- #1 K253531 Alexis® Lighted Wound Protector-Retractor…score 13.9 · 1 generation · no Class I recall
- #2 Held for the reportin 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 |
|---|---|---|---|
| * | K041711 | Alexis Wound Retractor, Models C8312, C8301, C8302, C8303, C8304Summary page 2…f this type. For that reason, APPLIED created test protocols specifically designed to confirm safety and efficacy of the subject device relative to the predicate device (K04171 1). These tests include comparison of: * The leak rate of the device when the retracted wound is closed. * The leak rate of the… | 2004 |
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.
- 5 other devices also cite its predicate K041711.
How does its category compare?
All KGW devicesKGW Ring (Wound Protector), Drape Retention, Internal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · KGW
2so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · KGW
Too few KGW 510(k)s in any year since 2007 to give a median.
Recalls per year · KGW
No recall names KGW since 2007.
Adverse event reports per year · KGW
15in 2025
MAUDE reports naming product code KGW, 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 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 12 |
| 2017 | 0 | — | 0 | 58 |
| 2018 | 0 | — | 0 | 13 |
| 2019 | 0 | — | 0 | 11 |
| 2020 | 0 | — | 0 | 12 |
| 2021 | 0 | — | 0 | 4 |
| 2022 | 0 | — | 0 | 18 |
| 2023 | 0 | — | 0 | 13 |
| 2024 | 0 | — | 0 | 19 |
| 2025 | 0 | — | 0 | 15 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The Alexis Laparoscopic System 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.
* Protect against wound contamination during laparoscopic and open surgery.
* Seal off the incision opening to permit insufflation of the peritoneum. Convert the incision wound to an additional trocar port site.
* Access the thoracic cavity or other soft tissue retraction during cardiac and general surgical procedures through an atraumatically retracted incision.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093296 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093296: Alexis Laparoscopic System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093296
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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