Browse hierarchy: [General Hospital (HO)](/submissions/HO) → [Subpart G — General Hospital and Personal Use Miscellaneous Devices](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices) → [21 CFR 880.6850](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6850) → KCT — Sterilization Wrap Containers, Trays, Cassettes & Other Accessories # KCT · Sterilization Wrap Containers, Trays, Cassettes & Other Accessories _General Hospital · 21 CFR 880.6850 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KCT ## Overview - **Product Code:** KCT - **Device Name:** Sterilization Wrap Containers, Trays, Cassettes & Other Accessories - **Regulation:** [21 CFR 880.6850](/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/880.6850) - **Device Class:** 2 - **Review Panel:** [General Hospital](/submissions/HO) - **3rd-party reviewable:** yes ## 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. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 277) Showing 20 most recent of 277 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K253791](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KCT/K253791.md) | PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid | DePuy Mitek, Inc. | Feb 26, 2026 | SESE | | [K251614](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KCT/K251614.md) | Stainless Steel Surgical Kits | Dentsply Sirona, Inc. | Feb 6, 2026 | SESE | | [K251756](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KCT/K251756.md) | Sterilization Trays | Paragon Implant Mfg., LLC | Nov 14, 2025 | SESE | | [K251300](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KCT/K251300.md) | Plastic Surgical Kits | Dentsply Sirona, Inc. | Jul 22, 2025 | SESE | | [K243425](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KCT/K243425.md) | Guided DAS Surgical Kit | Talladium España, SL | Jul 22, 2025 | SESE | | [K243589](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KCT/K243589.md) | PAL Sterilization Case | Microaire Surgical Instruments, LLC | Jun 20, 2025 | SESE | | [K242762](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KCT/K242762.md) | Aesculap Aicon® Series Container System | Aesculap, Inc. | May 13, 2025 | SESE | | [K250029](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KCT/K250029.md) | ONE TRAY® Sealed Sterilization Container System | Innovative Sterilization Technologies | May 1, 2025 | SESE | | [K241927](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KCT/K241927.md) | Synthes Graphic Case & Tray System | Synthes GmbH | Mar 28, 2025 | SESE | | [K242564](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KCT/K242564.md) | Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant Surgical Kit, Glidewell™ Prosthetic Kit) | Prismatik Dentalcraft, Inc. | Mar 21, 2025 | SESE | | [K242023](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KCT/K242023.md) | Microdent Sterilization Cassette | Implant Microdent System S.L.U. | Feb 19, 2025 | SESE | | [K243317](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KCT/K243317.md) | NUVENTUS NV.C™ Surgical Cassette and Tray | Infinitum Eta, Ltd. | Feb 11, 2025 | SESE | | [K242834](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KCT/K242834.md) | System 9 Sterile Battery Container | Stryker Instruments | Jan 16, 2025 | SESE | | [K243128](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KCT/K243128.md) | Klockner Kits | SOADCO, S.L. | Dec 18, 2024 | SESE | | [K241492](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KCT/K241492.md) | Guided Surgery Kit Cases | JJGC Indústria e Comércio de Materiais Dentários S.A. | Aug 23, 2024 | SESE | | [K240898](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KCT/K240898.md) | SteriTite rigid reusable sterilization container with MediTray Products | Case Medical | Jul 31, 2024 | SESE | | [K241050](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KCT/K241050.md) | CrossRoads Modular Tray System | Crossroads Extremity Systems | Jul 16, 2024 | SESE | | [K241378](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KCT/K241378.md) | S.I.N. Instrument Kits | S.I.N. - Sistema DE Implante Nacional S.A. | Jul 12, 2024 | SESE | | [K231291](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KCT/K231291.md) | Perforated Baskets | Richard Wolf Medical Instruments Corporation | Jun 3, 2024 | SESE | | [K233578](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KCT/K233578.md) | BAHADIR STERILIZATION CONTAINERS | Bahadir USA, LLC | Mar 22, 2024 | SESE | ## Top Applicants - Aesculap, Inc. — 12 clearances - STERIS Corporation — 11 clearances - Summit Medical, Inc. — 8 clearances - Jjgc Industria E Comercio DE Materiais Dentarios S.A. — 7 clearances - Intuitive Surgical, Inc. — 6 clearances --- **Source:** [https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KCT](https://fda.innolitics.com/submissions/HO/subpart-g%E2%80%94general-hospital-and-personal-use-miscellaneous-devices/KCT) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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