Data / Medical devices / United States / Wassenburg Medical, Inc.
Wassenburg Medical, Inc.: FDA-registered device maker in Ivyland, PA, United States, 3 510(k) clearances
Wassenburg Medical, Inc. is registered with the FDA (registration 3007082252) in Ivyland, PA, United States. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 19, 2024. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007082252
- FEI number
- 2523209
- Address
- 144 Railroad Drive, Ivyland, PA, United States, 18974
- Owner or operator
- Wassenburg Medical, Inc. (2523209)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- May 12, 2017
- Registered through
- 2026
- Brand names listed
- DRY320, Pre-Processing Sink, Scope-Assist Flushing Sink, Storage Cabinet, Model 20000, System 82 Plus 2, System 83 Plus 9, System 83 Revolve, TC-6 Cart
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Cleaning, For Endoscope | FEB | 2 | Manufacturer | accessdata.fda.gov |
| Adaptor, Bulbs, Miscellaneous, For Endoscope | FFY | 1 | Complaint file establishment, Repackager or relabeler | accessdata.fda.gov |
| Unit, Drying | JRJ | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 19, 2024 | K241168 | System 83 Revolve Endoscope Washer/Disinfector | FEB | Substantially Equivalent | Wassenburg Medical, Inc. | accessdata.fda.gov |
| March 30, 2020 | K173590 | System 83 Plus Washer/Disinfector | FEB | Substantially Equivalent | Custom Ultrasonics, Inc. | accessdata.fda.gov |
| April 28, 2017 | K162120 | Scope-Assist Flushing Sink | FEB | Substantially Equivalent | Custom Ultrasonics, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 6, 2016 | 74311 | Class II | Terminated | The System 83 Plus, Endoscope Washer/Disinfector Designed for the simultaneous reprocessing of up to two flexible submersible endoscopes that are used in the gastrointestinal and/or pulmonary tracts. | To warn customers that Custom Ultrasonics, Inc. System 83 Plus AERs should not be used for cleaning and/or high-level disinfection of duodenoscopes until further notice. | accessdata.fda.gov |
| March 12, 2013 | 65985 | Class II | Terminated | Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector. | Certain System 83 Plus 2 and System 83 Plus 9 units running the Windows 7 operating system were not fully validated prior to distribution. | accessdata.fda.gov |
| February 11, 2008 | 46877 | Not yet classified | Terminated | System 83 Plus Washer-Disinfector, Endoscope use, DOS based system, Custom Ultrasonics Inc., Buckingham, PA | Inadvertent selection of the "wash" cycle | accessdata.fda.gov |
| December 12, 2005 | 37702 | Not yet classified | Terminated | 83 plus Mini-flex with accessory crate, Custom Ultrasonics, Inc. | The device was marketed without a 510k | accessdata.fda.gov |
Compare with other makers
- All makers of Adaptor, Bulbs, Miscellaneous, For Endoscope
- All makers of Accessories, Cleaning, For Endoscope
- All makers of Unit, Drying
Updated December 19, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.