Keymed Fiberscope Auto Disinfector
FDA 510(k) K861821 · Keymed, Inc.
510(k) numberK861821
Submission
- Device name
- Keymed Fiberscope Auto Disinfector
- Applicant
- Keymed, Inc.
Essex Ss2 5qh England, GB - Received
- May 12, 1986
- Decision date
- February 12, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- NVE – Washer, Cleaner, Automated, Endoscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
This automated device is intended to be used to clean endoscopes. Endoscopes that are intended to be cleaned by the automated cleaner system should have been pre-cleaned and tested for leaks and lumen obstructions according to the instrument manufacturer's instructions and current professional practices prior to processing in the system. The system includes a chemical dispensing system that…
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| 510(k) | Device | Decision |
|---|---|---|
| K100803 | Olympus Flushing Pump Ofp Model: OFP-1FEQ · Special | 04/22/2010SE |
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| K881004 | Olympus-Keymed Endoscopic CO2 Regulator, Model EcrFCX · Traditional | 05/12/1988SE |
| 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 |
| K860704 | The Keymed Sigmoidoscope Disinfection StandNZA · Traditional | 06/17/1986SE |
| 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 Keymed Fiberscope Auto Disinfector cleared by the FDA?
Keymed Fiberscope Auto Disinfector (K861821) received a 510(k) decision of Substantially Equivalent on February 12, 1987, 276 days after the submission was received.
What is the product code of K861821?
The FDA product code is NVE – Washer, Cleaner, Automated, Endoscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.