510(k) K063753
K063753 is an FDA 510(k) premarket notification submitted by Aci, Inc. for the device "GFX NERVE ABLATION SYSTEM". The FDA issued a decision of Substantially Equivalent on June 20, 2007. The device falls under product code GXD (Generator, Lesion, Radiofrequency), a Class II device regulated under 21 CFR 882.4400. Aci, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 20, 2007
- Date Received
- December 19, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Generator, Lesion, Radiofrequency
- Device Class
- Class II
- Regulation Number
- 882.4400
- Review Panel
- NE
- Submission Type