Clearance Summary
KSEA SEMI-RIGID HYSTEROSCOPE AND ACCESSORIES received FDA 510(k) clearance under submission number K971518, sponsored by KARL STORZ Endoscopy-America, 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 1997-07-24.
- Submission: K971518
- Applicant / Sponsor: KARL STORZ Endoscopy-America, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1690
- Decision date: 1997-07-24
Classification & Regulation
This clearance is catalogued under FDA product code HIH and 21 CFR 884.1690, within the Obstetrics/Gynecology review panel as a Class II device.