Scope Buddy Plus
Scope Buddy Plus pumps detergent solution and rinse water through the channels of flexible, immersible endoscopes during manual cleaning. It delivers the fluid volumes specified by the…
Scope Buddy Plus pumps detergent solution and rinse water through the channels of flexible, immersible endoscopes during manual cleaning. It delivers the fluid volumes specified by the endoscope manufacturer as part of that manufacturer’s reprocessing procedure.
An external peristaltic pump moves fluid from a container, basin, or sink through connection tubing into the endoscope channels. A software-controlled interface and built-in timer govern delivery. The tubing can be used with multiple endoscopes within a 24-hour period.
Listed Item
Scope Buddy Plus Endoscope Flushing Aid
Reprocessing Scope
Connection tubing is discarded after 24 hours. Scope Buddy Plus is limited to the manual cleaning phase; it does not perform high-level disinfection or replace the endoscope manufacturer’s complete reprocessing instructions.
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) | K162128 |
| Record published | 2017-08-16 |
| Record revised | 2022-12-21 (version 9) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SBP-1000 | 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
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.