KCT · Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
General Hospital · 21 CFR 880.6850 · Class 2
Overview
| Product Code | KCT |
|---|---|
| Device Name | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories |
| Regulation | 21 CFR 880.6850 |
| Device Class | Class 2 |
| Review Panel | General Hospital |
| 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 | PUREVUE Quick Connect Cannula System Tray; PUREVUE Quick Connect Cannula System Lid | DePuy Mitek, Inc. | Feb 26, 2026 | SESE |
| K251614 | Stainless Steel Surgical Kits | Dentsply Sirona, Inc. | Feb 6, 2026 | SESE |
| K251756 | Sterilization Trays | Paragon Implant Mfg., LLC | Nov 14, 2025 | SESE |
| K251300 | Plastic Surgical Kits | Dentsply Sirona, Inc. | Jul 22, 2025 | SESE |
| K243425 | Guided DAS Surgical Kit | Talladium España, SL | Jul 22, 2025 | SESE |
| K243589 | PAL Sterilization Case | Microaire Surgical Instruments, LLC | Jun 20, 2025 | SESE |
| K242762 | Aesculap Aicon® Series Container System | Aesculap, Inc. | May 13, 2025 | SESE |
| K250029 | ONE TRAY® Sealed Sterilization Container System | Innovative Sterilization Technologies | May 1, 2025 | SESE |
| K241927 | Synthes Graphic Case & Tray System | Synthes GmbH | Mar 28, 2025 | SESE |
| K242564 | Autoclavable Cassette (Glidewell HT Implant Guided Surgical Kit, Glidewell HT Implant Surgical Kit, Glidewell Prosthetic Kit) | Prismatik Dentalcraft, Inc. | Mar 21, 2025 | SESE |
| K242023 | Microdent Sterilization Cassette | Implant Microdent System S.L.U. | Feb 19, 2025 | SESE |
| K243317 | NUVENTUS NV.C Surgical Cassette and Tray | Infinitum Eta, Ltd. | Feb 11, 2025 | SESE |
| K242834 | System 9 Sterile Battery Container | Stryker Instruments | Jan 16, 2025 | SESE |
| K243128 | Klockner Kits | SOADCO, S.L. | Dec 18, 2024 | SESE |
| K241492 | Guided Surgery Kit Cases | JJGC Indústria e Comércio de Materiais Dentários S.A. | Aug 23, 2024 | SESE |
| K240898 | SteriTite rigid reusable sterilization container with MediTray Products | Case Medical | Jul 31, 2024 | SESE |
| K241050 | CrossRoads Modular Tray System | Crossroads Extremity Systems | Jul 16, 2024 | SESE |
| K241378 | S.I.N. Instrument Kits | S.I.N. - Sistema DE Implante Nacional S.A. | Jul 12, 2024 | SESE |
| K231291 | Perforated Baskets | Richard Wolf Medical Instruments Corporation | Jun 3, 2024 | SESE |
| K233578 | 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
