AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm
FDA 510(k) clearance K182258 · decided 2018-09-21
Clearance details
- K-number
- K182258
- Device name
- AquaShield System CO2 ; AquaShield System CO2 - PENTAX ; AquaShield System CO2 - Fujifilm
- Applicant
- United States Endoscopy Group, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-08-21
- Decision date
- 2018-09-21
- Days to decision
- 31 days
- Clearance type
- Special
- Product code
- FEQ
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Mentor, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.