Clearance Summary
KARL STORZ INFANT, BALLOON VAGINOSCOPE, VAGINOSCOPE SHEATH, FIBER OPTIC LIGHT CARRIERS, ADJUSTABLE MAGNIFIERS received FDA 510(k) clearance under submission number K950639, 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 1995-06-19.
- Submission: K950639
- Applicant / Sponsor: KARL STORZ Endoscopy-America, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1630
- Decision date: 1995-06-19
Classification & Regulation
This clearance is catalogued under FDA product code MOK and 21 CFR 884.1630, within the Obstetrics/Gynecology review panel as a Class II device.