Advantage Plus Pass-Thru
The Advantage Plus Pass-Thru is an automated endoscope reprocessor for high-level disinfection of heat-sensitive endoscopes and related accessories. Endoscopes must be manually cleaned…
The Advantage Plus Pass-Thru is an automated endoscope reprocessor for high-level disinfection of heat-sensitive endoscopes and related accessories. Endoscopes must be manually cleaned before entering the system. The unit fits into a dividing wall so staff load used endoscopes on one side and remove disinfected endoscopes from the other.
The system checks channel connections, blockages and outer sheath leaks before washing and disinfection. It uses Intercept Plus detergent and Rapicide PA disinfectant. Water dilutes the disinfectant, while the system monitors its temperature. Following disinfection, the endoscope is rinsed and dried.
Disinfection Conditions
The high-level disinfection cycle uses at least 850 ppm peracetic acid at 30°C for five minutes. The user tests a sample for the minimum recommended concentration before the solution is drained.
Who Else Makes It
Registered in Zhejiang. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Saint-Gobain Life Sciences (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 5 |
Record
| Listed by | Medivators Inc, United States |
|---|---|
| FDA product code | FEB |
| Device type | Accessories, Cleaning, For Endoscope |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K172677 |
| Record published | 2018-02-06 |
| Record revised | 2023-02-27 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1-2-610.003 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Medivators Hookup | Medivators Inc | 333 |
| Evotech™ | Advanced Sterilization Products Services Inc. | 104 |
| Connecting Tube | Olympus Medical Systems Corp. | 47 |
| Accessories, Cleaning, For Endoscope | Steris Corporation | 39 |
| Accessories, Cleaning, For Endoscope | Pentax of America, Inc. | 24 |
| Accessories, Cleaning, For Endoscope | Richard Wolf Gmbh | 16 |
| ASP Aeroflex™ | Advanced Sterilization Products Services Inc. | 10 |
| Scope Buddy Plus Tubing | Medivators Inc | 9 |
| Accessories, Cleaning, For Endoscope | Corporation Steris Canada | 8 |
| Scope Assist Flushing Sink (Safs) | Wassenburg Medical, Inc. | 6 |
| System 83 Plus | Wassenburg Medical, Inc. | 4 |
| Leak Test AIR Tube | Olympus Medical Systems Corp. | 4 |
Showing 12 of 48. All products under Accessories, Cleaning, For Endoscope
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K213833 | 2022-01-14 |
| K172677 | 2017-12-19 |
| K162128 | 2016-12-21 |
| K914145 | 1994-02-22 |
Recalls Naming This Product
1 recall names this product by its own identifier, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Steris Corporation | 510(k) number | 2023-11-13 | Class II | Process control | Identification label on affected hookups could become illegible over time due to the label’s ink coming off. This may potentially prevent users from being able to effectively identify the hookup and may ultimately result in postponement of | 2545 US; 992 OUS |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2010-06-15 | Not classified | Labeling False and Misleading | The DSD hook up Application Guide incorrectly recommends use of the Medivators DSD-110-HU0109 endoscope hookup to connect the Pentax EG-3630U Ultrasound Endoscope to a Medivators DSD endoscope reprocessor or Medivators Scope Buddy Endoscope | 185 | 2011-12-17 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.