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/productcode/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 279)

Showing 20 most recent of 279 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K260726](/device/K260726.md) | Straumann® ProClean™ Cassette (041.800 ; 041.801) | Institut Straumann AG | Jun 3, 2026 | SESE |
| [K252854](/device/K252854.md) | SteriTite Container System with MediTray Products | Case Medical, Inc. | Jun 3, 2026 | SESE |
| [K253791](/device/K253791.md) | PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System Lid | DePuy Mitek, Inc. | Feb 26, 2026 | SESE |
| [K251614](/device/K251614.md) | Stainless Steel Surgical Kits | Dentsply Sirona, Inc. | Feb 6, 2026 | SESE |
| [K251756](/device/K251756.md) | Sterilization Trays | Paragon Implant Mfg., LLC | Nov 14, 2025 | SESE |
| [K251300](/device/K251300.md) | Plastic Surgical Kits | Dentsply Sirona, Inc. | Jul 22, 2025 | SESE |
| [K243425](/device/K243425.md) | Guided DAS Surgical Kit | Talladium España, SL | Jul 22, 2025 | SESE |
| [K243589](/device/K243589.md) | PAL Sterilization Case | Microaire Surgical Instruments, LLC | Jun 20, 2025 | SESE |
| [K242762](/device/K242762.md) | Aesculap Aicon® Series Container System | Aesculap, Inc. | May 13, 2025 | SESE |
| [K250029](/device/K250029.md) | ONE TRAY® Sealed Sterilization Container System | Innovative Sterilization Technologies | May 1, 2025 | SESE |
| [K241927](/device/K241927.md) | Synthes Graphic Case & Tray System | Synthes GmbH | Mar 28, 2025 | SESE |
| [K242564](/device/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](/device/K242023.md) | Microdent Sterilization Cassette | Implant Microdent System S.L.U. | Feb 19, 2025 | SESE |
| [K243317](/device/K243317.md) | NUVENTUS NV.C™ Surgical Cassette and Tray | Infinitum Eta, Ltd. | Feb 11, 2025 | SESE |
| [K242834](/device/K242834.md) | System 9 Sterile Battery Container | Stryker Instruments | Jan 16, 2025 | SESE |
| [K243128](/device/K243128.md) | Klockner Kits | SOADCO, S.L. | Dec 18, 2024 | SESE |
| [K241492](/device/K241492.md) | Guided Surgery Kit Cases | JJGC Indústria e Comércio de Materiais Dentários S.A. | Aug 23, 2024 | SESE |
| [K240898](/device/K240898.md) | SteriTite rigid reusable sterilization container with MediTray Products | Case Medical | Jul 31, 2024 | SESE |
| [K241050](/device/K241050.md) | CrossRoads Modular Tray System | Crossroads Extremity Systems | Jul 16, 2024 | SESE |
| [K241378](/device/K241378.md) | S.I.N. Instrument Kits | S.I.N. - Sistema DE Implante Nacional S.A. | Jul 12, 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

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**Source:** [https://fda.innolitics.com/productcode/KCT](https://fda.innolitics.com/productcode/KCT)

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