Clearance Summary
KSEA HYDROMAT 263110-20 PRESSURE CHAMBERS AND ACCESSORIES received FDA 510(k) clearance under submission number K972488, sponsored by Karl Storz Endoscopy. 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 1998-01-22.
- Submission: K972488
- Applicant / Sponsor: Karl Storz Endoscopy
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1720
- Decision date: 1998-01-22
Classification & Regulation
This clearance is catalogued under FDA product code HET and 21 CFR 884.1720, within the Obstetrics/Gynecology review panel as a Class II device.