Clearance Summary
MODIFICATION TO CAVERMAP SURGICAL AID received FDA 510(k) clearance under submission number K031527, sponsored by Blue Torch Medical Technologies. The device was reviewed via the Special premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2003-06-05.
- Submission: K031527
- Applicant / Sponsor: Blue Torch Medical Technologies
- Clearance pathway: Special
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.4730
- Decision date: 2003-06-05
Classification & Regulation
This clearance is catalogued under FDA product code FGM and 21 CFR 876.4730, within the Gastroenterology, Urology review panel as a Class I device.