Accessories, Germicide, Cleaning, For Endoscopes
The Accessories, Germicide, Cleaning, For Endoscopes (product code NZA) are high-level disinfection accessories used for reprocessing reusable, heat-sensitive endoscopic devices to ensure patient safety between uses. It is classified as FDA Class 2, requiring 510(k) clearance, and is regulated under 21 CFR 876.1500 within the Gastroenterology and Urology specialty. If reusable, validated reprocessing instructions must be included in any 510(k) submission, and the device carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- NZA
- Device Class
- FDA class 2
- Regulation Number
- 876.1500
- Medical Specialty
- Gastroenterology, Urology
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
Definition
High level disinfection of reusable, heat-sensitive devices If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K232918 | enspire 300 Series Automated Endoscope Reprocessor | Oct 03, 2023 | Substantially Equivalent | STERIS Corporation |
| K230560 | enspire 300 Series Automated Endoscope Reprocessor System | Jul 21, 2023 | Substantially Equivalent | STERIS Corporation |
| K220361 | Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide | Mar 10, 2022 | Substantially Equivalent | STERIS Corporation |
| K203223 | Reliance EPS Endoscope Processing System and Reliance DG Dry Germicide | Jan 28, 2021 | Substantially Equivalent | Steris |
| K200989 | Reliance Endoscope Processing System | May 14, 2020 | Substantially Equivalent | STERIS Corporation |
| K123768 | RELIANCE ADVANCE ENDOSCOPE PROCESSING SYSTEM | Jul 26, 2013 | Substantially Equivalent | STERIS Corporation |
| K110453 | RELIANCE ENDOSCOPE PROCESSING SYSTEM | Mar 16, 2011 | Substantially Equivalent | STERIS Corporation |
| K102244 | RELIANCE ENDOSCOPE PROCESSING SYSTEM | Dec 03, 2010 | Substantially Equivalent | STERIS Corporation |
| K040049 | THE RELIANCE ENDOSCOPE PROCESSING SYSTEM | Dec 17, 2004 | Substantially Equivalent | STERIS Corporation |
| K860704 | THE KEYMED SIGMOIDOSCOPE DISINFECTION STAND | Jun 17, 1986 | Substantially Equivalent | Keymed, Inc. |
| K841331 | OLYMPUS KC-10 MOBILE DISINFEC-STAT | Jul 19, 1984 | Substantially Equivalent | Keymed, Inc. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.