Medivators Advantage Plus Endoscope Reprocessing System, Rapicide Pa High Level Disinfectant
FDA 510(k) K082988 · Medivators Reprocessing Systems
510(k) numberK082988
Submission
- Device name
- Medivators Advantage Plus Endoscope Reprocessing System, Rapicide Pa High Level Disinfectant
- Applicant
- Medivators Reprocessing Systems
Minneapolis, MN, US - Received
- October 7, 2008
- Decision date
- February 13, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FEB – Accessories, Cleaning, For Endoscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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).
Other 510(k)s with product code FEB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K241168 | System 83 Revolve Endoscope Washer/DisinfectorFEB · Traditional | Wassenburg Medical, Inc. | 12/19/2024SE |
| K243433 | enspire 3000 Cleaning and Liquid Chemical Sterilant Processing SystemFEB · Special | STERIS Corporation | 12/02/2024SE |
| K230930 | enspire 3000 Cleaning and Liquid Chemical Sterile Processing SystemFEB · Traditional | STERIS Corporation | 06/30/2023SE |
| K213833 | SCOPE BUDDY PLUS Endoscope Flushing AidFEB · Special | Medivators, Inc. | 01/14/2022SE |
| K201920 | Endoscope Reprocessor OER-EliteFEB · Special | Olympus Medical Systems Corp. | 09/01/2020SE |
| K173590 | System 83 Plus Washer/DisinfectorFEB · Traditional | Custom Ultrasonics, Inc. | 03/30/2020SE |
| K190969 | ENDOSCOPE REPROCESSOR OER-EliteFEB · Traditional | Olympus Medical Systems Corp. | 07/09/2019SE |
| K181472 | AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC MonitorFEB · Traditional | Advanced Sterilization Products (Asp) | 04/23/2019SE |
| K181865 | Acu-sInQ Complete Endoscope Cleaning Aid SystemFEB · Traditional | STERIS Corporation | 12/14/2018SE |
| K172677 | Advantage Plus Pass-ThruFEB · Traditional | Medivators, Inc. | 12/19/2017SE |
More from Medivators, Inc.
Questions and answers
When was Medivators Advantage Plus Endoscope Reprocessing System, Rapicide Pa High Level Disinfectant cleared by the FDA?
Medivators Advantage Plus Endoscope Reprocessing System, Rapicide Pa High Level Disinfectant (K082988) received a 510(k) decision of Substantially Equivalent on February 13, 2009, 129 days after the submission was received.
What is the product code of K082988?
The FDA product code is FEB – Accessories, Cleaning, For Endoscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.