DSD-201
DSD-201, 120V Reprocessing System
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) | K914145 |
| Record published | 2016-09-20 |
| Record revised | 2023-04-25 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Distribution end date | 2023-04-25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DSD-201 120V | Withdrawn |
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 | Closed |
|---|---|---|---|---|---|---|---|
| Medivators Inc | 510(k) number | 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.