System 83 Revolve Endoscope Washer/Disinfector
FDA 510(k) clearance K241168 · decided 2024-12-19
Clearance details
- K-number
- K241168
- Device name
- System 83 Revolve Endoscope Washer/Disinfector
- Applicant
- Wassenburg Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2024-04-26
- Decision date
- 2024-12-19
- Days to decision
- 237 days
- Clearance type
- Traditional
- 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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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.