Clearance Summary
CAVERMAP SURGICAL AID received FDA 510(k) clearance under submission number K041732, sponsored by Blue Torch Medical Technologies. 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 2004-09-21.
- Submission: K041732
- Applicant / Sponsor: Blue Torch Medical Technologies
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.4730
- Decision date: 2004-09-21
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.