← Product Code [FRG](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRG) · K961227 # JJ SKINNER CAREKITS WOUND CARE MANAGEMENT/DRESSING CHANGE TRAY (K961227) _J.J. Skinner, Inc. · FRG · Jun 10, 1996 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRG/K961227 ## Device Facts - **Applicant:** J.J. Skinner, Inc. - **Product Code:** [FRG](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRG.md) - **Decision Date:** Jun 10, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.6850 - **Device Class:** Class 2 - **Review Panel:** General Hospital - **Attributes:** Therapeutic ## Indications for Use The JJ Skinner CareKits™ Wound Care Management/Dressing Change Tray is intended to be used by Healthcare professionals for wound care management, including, cleansing, irrigation, debridement, and dressing changes. ## Device Story Assembly of medical products for wound care management; includes various legally marketed, exempt, or grandfathered medical devices; packaged in sterile Tyvek®/polyethylene pouch; disposable, single-use; intended for healthcare professional convenience; facilitates cleansing, irrigation, debridement, and dressing changes; no new uses claimed. ## Clinical Evidence No clinical evaluations were completed. ## Technological Characteristics Sterile, disposable, single-use tray; components packaged in Tyvek®/polyethylene pouch; assembly of legally marketed medical devices for wound care. ## Regulatory Identification A sterilization wrap (pack, sterilization wrapper, bag, or accessories, is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} JUN 10 1996 K961227 ATTACHMENT 1 Page 1 of 2 ## 510(K) SUMMARY ### JJ Skinner CareKits™ Wound Care Management/Dressing Change Tray **Submitter Information:** JJ Skinner Inc. Stark Bldg. Suite 825 455 South Fourth Avenue Louisville, KY 40202 **510(k) Summary Prepared By:** Carolann Kotula mdi Consultants, Inc. 55 Northern Blvd. Great Neck, NY 11021 (516) 482-9001 **Date 510(k) Summary Prepared:** March 20, 1996 **Name of the Device:** **Trade or Proprietary Name:** JJ Skinner CareKits™ Wound Care Management/Dressing Change Tray **Common Name:** Wound care kit/tray; dressing change kit/tray **Classification Name:** Kit, Wound Dressing (Product Code: 79MCY) **Identification of Legally Marketed Device to which the Submitter Claims Equivalence:** The JJ Skinner CareKits™ Wound Care Management/Dressing Change Tray is an assembly of medical products sterilized within a Tyvek®/polyethylene pouch. The trays are sterile, disposable, and single use. The primary purpose is for the convenience of the Healthcare professional. The trays are custom to the customer, and include a variety of medical devices that are legally marketed, are exempt, or are grandfathered. These components of the tray are commonly used for wound {1} ATTACHMENT 1 Page 2 of 2 management, and JJ Skinner is not claiming or causing new uses through the intended use of the tray. ## Intended Use of the Subject Devices: The JJ Skinner CareKits™ Wound Care Management/Dressing Change Tray is intended to be used by Healthcare professionals for wound care management, including, cleansing, irrigation, debridement, and dressing changes. ## Technological Characteristics of the Subject Device: The technological characteristics of JJ Skinner CareKits™ Wound Care Management/Dressing Change Trays and the predicate device are substantially equivalent as supported by the comparison of similar significant features, components, and intended use. No clinical evaluations were completed. --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRG/K961227](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/FRG/K961227) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com