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The Alexis retractor is a wound protector-retractor made by Applied Medical Resources Corporation: a device placed in a surgical incision to hold it open and cover the wound edges. FDA lists it under product code KGW (internal drape retention ring) and regulates it as a Class II surgical drape accessory under 21 CFR 878.4370. This guide is general product information for lab, clinic and supply staff, not medical advice, and it does not describe how to use the device on a patient.
Definition and scope
“Alexis” is a product name, not a generic device category. The category is the wound protector-retractor: a device that retracts the edges of an incision and shields the exposed wound. It differs from the hand-held, self-retaining and table-mounted instruments covered in what a surgical retractor is, because it lines the whole incision rather than pulling tissue aside at one point.
In FDA’s classification database, product code KGW is named “Ring (Wound Protector), Drape Retention, Internal” (regulation 878.4370, class 2, General and Plastic Surgery panel; openFDA data last updated 2026-10-19, checked 2026-10-30). The regulation describes surgical drapes and accessories as including “a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges” (21 CFR 878.4370, checked 2026-10-30).
How FDA describes its intended use
FDA’s clearance letter K253531 (decision 2026-02-23), covers the Alexis Lighted Wound Protector-Retractor in rigid (CL402) and flexible (CL302) medium sizes. Its Indications for Use say the device “allows the surgeon to access the abdominal cavity through an atraumatically retracted wound, providing maximum exposure with minimum incision size,” and that “in addition to incision retraction, it is intended to provide supplemental illumination and protect against wound contamination during both laparoscopic and open surgery.”
The same document says the device is “capable of temporarily closing an incision to maintain pneumoperitoneum during laparoscopic surgery, or to serve as an additional trocar port site,” and that it “may be used to access the thoracic cavity or other soft tissue retraction during cardiac and general surgical procedures.” For the terms, see what a trocar is and what a laparoscope is.
The letter also states that the device was cleared on substantial equivalence for these indications, which is not the same as FDA approval, and that it remains subject to registration and listing, labeling, medical device reporting, quality system and UDI requirements.
One name, several FDA records
Searching openFDA for “Alexis” returns separate 510(k) records, all with Applied Medical as applicant unless noted. They show the label growing over time. This is a database snapshot as of 2026-10-30, not a product catalogue.
| 510(k) | Decision date | Device name in the record |
|---|---|---|
| K031889 | 2003-09-22 | Alexis Wound Retractor |
| K041711 | 2004-08-26 | Alexis wound retractor, models C8312 and C8301 to C8304 |
| K100120 | 2010-04-02 | Alexis Orthopaedic Wound Retractor |
| K113268 | 2013-02-08 | Alexis O Wound Protector/Retractor |
| K253531 | 2026-02-23 | Alexis Lighted Wound Protector-Retractor, rigid medium (CL402) and flexible medium (CL302) |
| K260982 | 2026-04-24 | Lighted, flexible XS (CL312), S (CL301), M (CL302), L (CL303); rigid S (CL401), M (CL402), L (CL403) |
Two cautions from the same search. K211043 (2022-03-31) is the Alexis Contained Extraction System, a different product. Separate kit clearances from another company (K111881, K113496, K231891) bundle an Alexis wound retractor with other components; they are kit records, not Alexis device records.
What the infection-prevention evidence says
Evidence on this device class is about wound protectors or wound edge protectors as a group, not about Alexis specifically, and it does not show that any one brand performs better than another. Two meta-analyses of randomized trials agree on the overall direction and differ on colorectal surgery.
| Meta-analysis | Trials | Overall surgical site infection (SSI) | Colorectal surgery |
|---|---|---|---|
| Li et al., BJS Open 2022;6(3):zrac065 | 22 RCTs, 4,492 patients | RR 0.66 (95% CI 0.53 to 0.83) | RR 0.68 (0.46 to 1.01), no reduction shown |
| Liu et al., BMC Surgery 2025;25:72 | 19 RCTs, 4,779 participants | RR 0.63 (0.50 to 0.80), very low certainty | RR 0.58 (0.38 to 0.91), very low certainty |
The 2025 authors report moderate-certainty benefit in gastrointestinal surgery (RR 0.49, 0.36 to 0.67), no clear protective role in other types of abdominal surgery, and call for more studies for laparoscopic surgery. The 2022 paper found both single- and double-ringed devices effective and reported RR 0.59 for superficial SSI. For the wider infection-control picture, see surgical site infection (SSI) and SSI prevention bundle elements.
Where it matters for labs, clinics and supply decisions
- Check the exact record. The model code, size and rigid or flexible form are listed in the 510(k) record, so the code on a package can be matched to the clearance that covers it.
- Cleared is not approved. FDA’s letter frames the decision as substantial equivalence for stated indications; use outside those indications is not described by the record.
- Look up the device identifier. The FDA letter notes UDI requirements apply, and manufacturer UDI records are searchable in NLM’s AccessGUDID.
Common misunderstandings
- It is not a hand-held retractor. It is a wound protector that also retracts; see the retractor guide linked above for instrument types.
- “Alexis” does not mean one device. The name appears on abdominal, orthopaedic, lighted and extraction-system records.
- It is not a surgical drape. Product code KGW sits under 21 CFR 878.4370 because that regulation covers drape accessories including plastic wound protectors, as quoted above.
Frequently asked questions
What is an Alexis retractor used for?
FDA’s K253531 indications describe access to the abdominal cavity through a retracted wound, protection against wound contamination, supplemental illumination in the lighted version, and, in the stated cases, maintaining pneumoperitoneum or serving as a trocar port site.
Is an Alexis retractor a retractor or a drape accessory?
Both labels apply. It retracts the incision, and FDA regulates the ring-type wound protector product code under the surgical drape accessories regulation, 21 CFR 878.4370.
Is it FDA approved?
It is FDA cleared through 510(k) premarket notification. FDA’s letter states that clearance reflects substantial equivalence and is not approval.
Sources
- FDA 510(k) clearance letter and Indications for Use, K253531, decision 2026-02-23: https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253531.pdf (checked 2026-10-30).
- openFDA device 510(k) and classification data, last updated 2026-10-19: https://api.fda.gov/device/classification.json?search=product_code:KGW and https://api.fda.gov/device/510k.json?search=device_name:alexis (checked 2026-10-30).
- 21 CFR 878.4370, Surgical drapes and drape accessories: https://www.law.cornell.edu/cfr/text/21/878.4370 (checked 2026-10-30).
- Li et al., BJS Open 2022;6(3):zrac065: https://doi.org/10.1093/bjsopen/zrac065, PubMed https://pubmed.ncbi.nlm.nih.gov/35543265/ (checked 2026-10-30).
- Liu et al., BMC Surgery 2025;25:72: https://doi.org/10.1186/s12893-025-02809-9, PubMed https://pubmed.ncbi.nlm.nih.gov/39966888/ (checked 2026-10-30).
- NLM AccessGUDID: https://accessgudid.nlm.nih.gov/ (checked 2026-10-30).
