Clearance Summary
NEZHAT-DORSEY ELECTROSURGICAL HAND CONTROL ATTACHMENTS, PENCIL-GRIP HANDLES & TRUMPET VALVE W/CUTTING & COAGULATION HANS received FDA 510(k) clearance under submission number K952070, sponsored by American Hydro-Surgical Instruments, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 1995-07-26.
- Submission: K952070
- Applicant / Sponsor: American Hydro-Surgical Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4160
- Decision date: 1995-07-26
Classification & Regulation
This clearance is catalogued under FDA product code KNF and 21 CFR 884.4160, within the Obstetrics/Gynecology review panel as a Class II device.