Advantage Plus Pass-Thru
FDA 510(k) K172677 · Medivators, Inc.
510(k) numberK172677
Submission
- Device name
- Advantage Plus Pass-Thru
- Applicant
- Medivators, Inc.
Minneapolis, MN, US - Received
- September 5, 2017
- Decision date
- December 19, 2017
- 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).
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| 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 |
| K162120 | Scope-Assist Flushing SinkFEB · Traditional | Custom Ultrasonics, Inc. | 04/28/2017SE |
More from Custom Ultrasonics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K231418 | ENDOGATOR Hybrid Irrigation TubingOCX · Traditional | 08/14/2023SE |
| K223040 | Endo SmartCapFAJ · Special | 03/01/2023SE |
| K213833 | SCOPE BUDDY PLUS Endoscope Flushing AidFEB · Special | 01/14/2022SE |
| K162128 | Scope Buddy Plus Endoscope Flushing AidFEB · Traditional | 12/21/2016SE |
| K160846 | AmplifEYEFED · Traditional | 07/14/2016SE |
| K152394 | Rapicide PA High-Level Disinfectant Test StripsJOJ · Traditional | 03/11/2016SE |
| K151522 | DEFENDO Bronchoscopy Suction ValveKTI · Traditional | 09/17/2015SE |
| K133724 | Minncare HDNIH · Traditional | 08/27/2014SE |
| K140753 | Endo Smart Bottle, Rinse and Insufflation SystemOCX · Special | 07/15/2014SE |
| K993042 | Medivators 5 Minute High-Level DisinfectantMED · Traditional | 08/17/2000SE |
Questions and answers
When was Advantage Plus Pass-Thru cleared by the FDA?
Advantage Plus Pass-Thru (K172677) received a 510(k) decision of Substantially Equivalent on December 19, 2017, 105 days after the submission was received.
What is the product code of K172677?
The FDA product code is FEB – Accessories, Cleaning, For Endoscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.