Clearance Summary
Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope Sheath received FDA 510(k) clearance under submission number K171336, sponsored by Henke-Sass, Wolf GmbH. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 2017-12-07.
- Submission: K171336
- Applicant / Sponsor: Henke-Sass, Wolf GmbH
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class II
- Regulation citation: 21 CFR 876.1500
- Decision date: 2017-12-07
Classification & Regulation
This clearance is catalogued under FDA product code FAJ and 21 CFR 876.1500, within the Gastroenterology, Urology review panel as a Class II device.