AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor
FDA 510(k) clearance K181472 · decided 2019-04-23
Clearance details
- K-number
- K181472
- Device name
- AEROFLEX(TM) Automatic Endoscope Reprocessor with AUTOSURE(TM) MRC Monitor
- Applicant
- Advanced Sterilization Products (Asp)
- Decision
- Substantially Equivalent
- Date received
- 2018-06-04
- Decision date
- 2019-04-23
- Days to decision
- 323 days
- Clearance type
- Traditional
- Product code
- FEB
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Irvin, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| System 83 Revolve Endoscope Washer/Disinfector (K241168) | Wassenburg Medical, Inc. | 2024-12-19 |
| enspire 3000 Cleaning and Liquid Chemical Sterilant Processing System (K243433) | STERIS Corporation | 2024-12-02 |
| enspire 3000 Cleaning and Liquid Chemical Sterile Processing System (K230930) | STERIS Corporation | 2023-06-30 |
| SCOPE BUDDY PLUS Endoscope Flushing Aid (K213833) | Medivators, Inc. | 2022-01-14 |
| Endoscope Reprocessor OER-Elite (K201920) | Olympus Medical Systems Corp. | 2020-09-01 |
| System 83 Plus Washer/Disinfector (K173590) | Custom Ultrasonics, Inc. | 2020-03-30 |
| ENDOSCOPE REPROCESSOR OER-Elite (K190969) | Olympus Medical Systems Corp. | 2019-07-09 |
| Acu-sInQ Complete Endoscope Cleaning Aid System (K181865) | STERIS Corporation | 2018-12-14 |
| Advantage Plus Pass-Thru (K172677) | Medivators, Inc. | 2017-12-19 |
| Scope-Assist Flushing Sink (K162120) | Custom Ultrasonics, Inc. | 2017-04-28 |
| Scope Buddy Plus Endoscope Flushing Aid (K162128) | Medivators, Inc. | 2016-12-21 |
| EVOTECH ECR (K152189) | Advanced Sterilization Products (Asp) | 2016-07-20 |
Recalls involving this device
No recalls on record reference this clearance.