Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4370](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4370) → KGW — Ring (Wound Protector), Drape Retention, Internal

# KGW · Ring (Wound Protector), Drape Retention, Internal

_General, Plastic Surgery · 21 CFR 878.4370 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGW

## Overview

- **Product Code:** KGW
- **Device Name:** Ring (Wound Protector), Drape Retention, Internal
- **Regulation:** [21 CFR 878.4370](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4370)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)

## Identification

A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes 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, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.

## Classification Rationale

Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

## Special Controls

*Classification.* Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.

## Recent Cleared Devices (8 of 8)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K253531](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGW/K253531.md) | Alexis® Lighted Wound Protector-Retractor, Rigid, Medium (CL402); Alexis® Lighted Wound Protector-Retractor, Flexible, Medium (CL302) | Applied Medical Resources Corporation | Feb 23, 2026 | SESE |
| [K113268](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGW/K113268.md) | ALEXIS O WOUND PROTECTOR/RETRACTOR | Applied Medical Resources Corp. | Feb 8, 2013 | SESE |
| [K100120](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGW/K100120.md) | ALEXIS ORTHOPAEDIC WOUND RETRACTOR | Applied Medical Resources Corp. | Apr 2, 2010 | SESE |
| [K093296](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGW/K093296.md) | ALEXIS LAPAROSCOPIC SYSTEM | Applied Medical Resources Corp. | Nov 5, 2009 | SESE |
| [K062907](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGW/K062907.md) | ALEXIS WOUND RETRACTOR | Applied Medical Resources | Jan 9, 2007 | SESE |
| [K041711](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGW/K041711.md) | ALEXIS WOUND RETRACTOR, MODELS C8312, C8301, C8302, C8303, C8304 | Applied Medical Resources Corp. | Aug 26, 2004 | SESE |
| [K840946](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGW/K840946.md) | MICROPOROUS HYPOALLERGENIC | Gainor Medical | Aug 17, 1984 | SESE |
| [K790306](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGW/K790306.md) | EDGE PROTECTOR, BARRIER | Surgikos, Inc. | Feb 22, 1979 | SESE |

## Top Applicants

- Applied Medical Resources Corp. — 4 clearances
- Applied Medical Resources — 1 clearance
- Applied Medical Resources Corporation — 1 clearance
- Gainor Medical — 1 clearance
- Surgikos, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGW](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGW)

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