Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™ Instrument Channel Caps
FDA 510(k) clearance K233752 · decided 2024-05-02
Clearance details
- K-number
- K233752
- Device name
- Dragonfly™ Pancreaticobiliary Scope; Dragonfly™ Digital Controller; Dragonfly™ Instrument Channel Caps
- Applicant
- CenterPoint Systems, LLC
- Decision
- Substantially Equivalent
- Date received
- 2023-11-22
- Decision date
- 2024-05-02
- Days to decision
- 162 days
- Clearance type
- Traditional
- Product code
- FBN
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- West Valley City, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.