510(k) K964365
K964365 is an FDA 510(k) premarket notification submitted by Omnitech Systems, Inc. for the device "RESECTOSCOPE CUTTING LOOP ELECTRODE". The FDA issued a decision of Substantially Equivalent on April 22, 1997. The device falls under product code FAS (Electrode, Electrosurgical, Active, Urological), a Class II device regulated under 21 CFR 876.4300. Omnitech Systems, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 22, 1997
- Date Received
- November 1, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode, Electrosurgical, Active, Urological
- Device Class
- Class II
- Regulation Number
- 876.4300
- Review Panel
- GU
- Submission Type