SYSTEM 83 PLUS
FDA 510(k) clearance K122172 · decided 2013-01-25
Clearance details
- K-number
- K122172
- Device name
- SYSTEM 83 PLUS
- Applicant
- Custom Ultrasonics
- Decision
- Substantially Equivalent
- Date received
- 2012-07-23
- Decision date
- 2013-01-25
- Days to decision
- 186 days
- Clearance type
- Special
- Product code
- FEB
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Ivyland, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Custom Ultrasonics System 83 Plus 2 and Plus 9 Endoscope Washer/Disinfector. recall (Z-0426-2014) | Custom Ultrasonics, Inc. | 2013-11-27 |