Clearance Summary
HSW Resection Instruments received FDA 510(k) clearance under submission number K173070, sponsored by Henke-Sass, Wolf GmbH. 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 2018-06-08.
- Submission: K173070
- Applicant / Sponsor: Henke-Sass, Wolf GmbH
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1690
- Decision date: 2018-06-08
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.