Scope Buddy Plus Blanking Cap
Scope Buddy Plus Air Water Blanking Cap for Olympus Endoscopes
1manufacturer
1catalogue number
4510(k) clearances naming this product code
1recall
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) | K213833 |
| Record published | 2022-12-20 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SB110HU1017 | 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.