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Sterigage Eo Ethyl Oxide Steril Indic

FDA 510(k)

Class II (US FDA 510(k))

510(k) K802634

by Organon, Inc.

Identifiers

510(k) Number
K802634 FDA 510(k)
FDA Product Code
JOJ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.2800 FDA 510(k)
Regulation Number
880.2800 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is an indicator for physical/chemical sterilization processes, specifically designed to monitor the adequacy of ethylene oxide sterilization. It consists of a known number of microorganisms with known resistance to the sterilization mode, contained in a protective package to assess sterilization effectiveness.

It is intended for use by healthcare providers to accompany products undergoing sterilization procedures. The device is supplied as a single-use indicator and is regulated under FDA 510(k) clearance K802634, with product code JOJ and classification as a Class II device for general hospital use.

Frequently asked questions

What is the Sterigage EO Ethyl. Oxide Steril. Indic. used for?

The Sterigage EO Ethyl. Oxide Steril. Indic. is used to monitor the adequacy of ethylene oxide sterilization processes. It contains a known number of resistant microorganisms in a protective package to assess whether sterilization conditions were effective, and is intended for use by healthcare providers accompanying products undergoing sterilization.

How is the Sterigage EO Ethyl. Oxide Steril. Indic. supplied and is it reusable?

The device is supplied as a single-use indicator. It is not designed for reuse and must be discarded after one use to ensure accurate monitoring of sterilization effectiveness, as reusing it could compromise the integrity of the biological challenge system.

What regulatory pathway was used for the Sterigage EO Ethyl. Oxide Steril. Indic.?

The Sterigage EO Ethyl. Oxide Steril. Indic. was cleared through the FDA 510(k) pathway under submission K802634. It is classified as a Class II device with product code JOJ and is regulated for general hospital use based on its substantial equivalence to a legally marketed predicate device.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: STERIGAGE EO ETHYL. OXIDE STERIL. INDIC. (K802634) — FDA 510(k ..., Sterigage Eo Ethyl. Oxide Steril. Indic. 510 (k) FDA Premarket ..., STERIGAGE EO ETHYL. OXIDE STERIL. INDIC. (K802634) — FDA 510(k ..., fda.innolitics.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Organon, Inc.

Sources (1)

  • FDA 510(k) K802634 24 fields · synced Sep 19, 2026