510(k) K041732
K041732 is an FDA 510(k) premarket notification submitted by Blue Torch Medical Technologies for the device "CAVERMAP SURGICAL AID". The FDA issued a decision of Substantially Equivalent on September 21, 2004. The device falls under product code FGM (Probe And Director, Gastro-Urology), a Class I device regulated under 21 CFR 876.4730. Blue Torch Medical Technologies has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 21, 2004
- Date Received
- June 25, 2004
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Probe And Director, Gastro-Urology
- Device Class
- Class I
- Regulation Number
- 876.4730
- Review Panel
- GU
- Submission Type