Clearance Summary
CANDELA URETHRAL/BLADDER SOUND received FDA 510(k) clearance under submission number K950633, sponsored by Candela Laser Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1995-03-06.
- Submission: K950633
- Applicant / Sponsor: Candela Laser Corp.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.5520
- Decision date: 1995-03-06
Classification & Regulation
This clearance is catalogued under FDA product code FBX and 21 CFR 876.5520, within the Gastroenterology, Urology review panel as a Class I device.