The Keymed Sigmoidoscope Disinfection Stand
FDA 510(k) K860704 · Keymed, Inc.
510(k) numberK860704
Submission
- Device name
- The Keymed Sigmoidoscope Disinfection Stand
- Applicant
- Keymed, Inc.
Essex Ss2 5qh England, GB - Received
- February 26, 1986
- Decision date
- June 17, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- NZA – Accessories, Germicide, Cleaning, For Endoscopes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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).
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| K230560 | enspire 300 Series Automated Endoscope Reprocessor SystemNZA · Traditional | STERIS Corporation | 07/21/2023SE |
| K220361 | Reliance EPS Endoscope Processing System and Reliance DG Dry GermicideNZA · Special | STERIS Corporation | 03/10/2022SE |
| K203223 | Reliance EPS Endoscope Processing System and Reliance DG Dry GermicideNZA · Traditional | Steris | 01/28/2021SE |
| K200989 | Reliance Endoscope Processing SystemNZA · Special | STERIS Corporation | 05/14/2020SE |
| K123768 | Reliance Advance Endoscope Processing SystemNZA · Traditional | STERIS Corporation | 07/26/2013SE |
| K110453 | Reliance Endoscope Processing SystemNZA · Special | STERIS Corporation | 03/16/2011SE |
| K102244 | Reliance Endoscope Processing SystemNZA · Traditional | STERIS Corporation | 12/03/2010SE |
| K040049 | The Reliance Endoscope Processing SystemNZA · Traditional | STERIS Corporation | 12/17/2004SE |
| K841331 | Olympus KC-10 Mobile Disinfec-StatNZA · Traditional | Keymed, Inc. | 07/19/1984SE |
More from Keymed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K100803 | Olympus Flushing Pump Ofp Model: OFP-1FEQ · Special | 04/22/2010SE |
| K921179 | Olympus-Keymed Disinfectant Fume Extractor DFE-20FEB · Traditional | 03/29/1993SE |
| K881004 | Olympus-Keymed Endoscopic CO2 Regulator, Model EcrFCX · Traditional | 05/12/1988SE |
| K861821 | Keymed Fiberscope Auto DisinfectorNVE · Traditional | 02/12/1987SE |
| K864801 | The Keymed Hi-Light 250 Light SourceGCT · Traditional | 12/24/1986SE |
| K862000 | Keymed Flexible Esophageal DilatorsKNQ · Traditional | 08/12/1986SE |
| K860528 | The Keymed Fiberscope Sterilization CaseKCT · Traditional | 07/15/1986SE |
| K861147 | UCS-2, Ultrasonic Cleaning SolutionFLG · Traditional | 06/23/1986SE |
| K851149 | Key Med Transendoscopic Vascular Detector TVD-1JAF · Traditional | 11/26/1985SE |
| K854304 | Keymed Office CouchFPO · Traditional | 11/12/1985SE |
Questions and answers
When was The Keymed Sigmoidoscope Disinfection Stand cleared by the FDA?
The Keymed Sigmoidoscope Disinfection Stand (K860704) received a 510(k) decision of Substantially Equivalent on June 17, 1986, 111 days after the submission was received.
What is the product code of K860704?
The FDA product code is NZA – Accessories, Germicide, Cleaning, For Endoscopes, a Class II (moderate risk) device regulated under 21 CFR 876.1500.