510(k) Report

510(k) · Cleared

Cleared

Alexis Wound Retractor, Models C8312, C8301, C8302, C8303, C8304

K041711510(k) TraditionalCleared Aug 26, 200464-day reviewClass II21 CFR 878.4370

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Applied Medical Resources Corp. · KGW Ring (Wound Protector), Drape Retention, Internal

Cleared on Aug 26, 2004 after a 64-day review. The FDA summary names its predicate without a number. 9 later devices descend from it.

Decided
Aug 26, 2004
Review
64 days
Class
Class II
Product code
KGW
Recalls
None
Predicates
0

9 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2026: 2 descendants cleared2011: 1 descendant cleared2012: 2 descendants cleared2009: 1 descendant cleared2014: 2 descendants cleared2023: 1 descendant cleared200020052010201520202025
  1. This deviceK041711 Alexis Wound Retractor, Models C8312, C8301, C8302, C8303, C8304Applied Medical Resources Corp. · 2004
  2. Descendant · cites it directly · 2 of its ownK120061 Wound ProtectorCovidien, Formerly US Surgical A Divison of Tyco H · 2012
  3. Descendant · cites it directly · 1 of its ownK253531 Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402)…Applied Medical Resources Corporation · 2026
  4. Descendant · cites it directly · 1 of its ownK140064 Surgisleeve Wound ProtectorCovidien · 2014
  5. Descendant · cites it directly · 1 of its ownK113496 Virture Male Sling System with Alexis Wound Retractor Convenience KitColoplast A/S · 2012
  6. Descendant · 2 generations on · 0 of its ownK260982 Alexis lighted wound protector-retractor, flexible, extra small…Applied Medical Resources Corporation · 2026

Showing 5 of 9 descendants. See all descendants

Descendants cleared per year

2009: 12011: 12012: 22014: 22023: 12026: 2
2009high 2 (2012) · low 0 (2010)2026

Most influential descendants

Showing 5 of 9 · See all
  • K120061Wound ProtectorCovidien, Formerly US Surgical A Divison of Tyco H · 2012 · cites it directly2descendants
  • K253531Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound…Applied Medical Resources Corporation · 2026 · cites it directly1descendant
  • K140064Surgisleeve Wound ProtectorCovidien · 2014 · cites it directly1descendant
  • K113496Virture Male Sling System with Alexis Wound Retractor Convenience KitColoplast A/S · 2012 · cites it directly1descendant
  • K260982Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted…Applied Medical Resources Corporation · 2026 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K041711Alexis Wound Retractor, Models C8312, C8301, C8302, C8303, C8304Applied Medical Resources Corp.2004—
+1K120061Wound ProtectorCovidien, Formerly US Surgical A Divison of Tyco H2012—
+1K253531Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis®…Applied Medical Resources Corporation2026—
+1K140064Surgisleeve Wound ProtectorCovidien2014—
+1K113496Virture Male Sling System with Alexis Wound Retractor Convenience KitColoplast A/S2012—
+2K260982Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis…Applied Medical Resources Corporation2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201110
201220
201420
202310
202620
FIG. 1 — Lineage of K041711, 2004–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K253531 Alexis® Lighted Wound Protector-Retractor…score 13.9 · 1 generation · no Class I recall
  2. #2 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*—Heartport Soft Tissue Retractor
Named without a submission number
—

What descends from it? (9)

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K120061Wound ProtectorCovidien, Formerly US Surgical A Divison of Tyco H20122
K253531Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound…Applied Medical Resources Corporation20261
K140064Surgisleeve Wound ProtectorCovidien20141
K113496Virture Male Sling System with Alexis Wound Retractor Convenience KitColoplast A/S20121
K111881Virtue Male Sling System and Alexis (R) Wound Retractor KitColoplast A/S20110
K093296Alexis Laparoscopic SystemApplied Medical Resources Corp.20090

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, K120061 (Covidien, Formerly US Surgical A Divison of Tyco H, 2012) has gone furthest, with 2 descendants of its own.

How does its category compare?

All KGW devices

KGW Ring (Wound Protector), Drape Retention, Internal: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KGW

2so far in 2026, the most since 2007

2007: 12009: 12010: 12013: 12026 (partial year): 2
2007high 2 (2026) · low 0 (2008)2026

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

2011: 12016: 122017: 582018: 132019: 112020: 122021: 42022: 182023: 132024: 192025: 15
2007high 58 (2017) · low 0 (2007)2025

MAUDE reports naming product code KGW, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—00
20080—00
20091—00
20101—00
20110—01
20120—00
20131—00
20140—00
20150—00
20160—012
20170—058
20180—013
20190—011
20200—012
20210—04
20220—018
20230—013
20240—019
20250—015
20262—0—

What is it indicated for?

The Applied Alexis Wound Retractor 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.

The smaller two sizes of Alexis are also intended to be used to:

* Seal off the incision opening to permit insufflating 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.

More from Applied Medical Resources Corp.

45 FDA decisions under this applicant name. See the company

  • K252740Voyant® Open Fusion Device (EB240/Open Fusion)Applied Medical Resources Corp. · 2025
  • K252442Kii Structural Balloon Access SystemApplied Medical Resources Corp. · 2025
  • K243152GelPOINT V-Path Transvaginal Access Platform with Retroperitoneal Access DeviceApplied Medical Resources Corp. · 2025
  • K201212Voyant Open Fusion DeviceApplied Medical Resources Corp. · 2020
  • K200598Voyant Maryland Fusion DeviceApplied Medical Resources Corp. · 2020

Recent decisions in KGW

The KGW category page

  • K260982Alexis lighted wound protector-retractor, flexible, extra small (cl312);Alexis lighted wound…Applied Medical Resources Corporation · 2026
  • K253531Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor…Applied Medical Resources Corporation · 2026
  • K113268Alexis O Wound Protector/RetractorApplied Medical Resources Corp. · 2013
  • K100120Alexis Orthopaedic Wound RetractorApplied Medical Resources Corp. · 2010
  • K093296Alexis Laparoscopic SystemApplied Medical Resources Corp. · 2009

https://510kreport.com/device/K041711 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041711: Alexis Wound Retractor, Models C8312, C8301, C8302, C8303, C8304.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041711

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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