Clearance Summary
SMITH & NEPHEW OPERATIVE HYSTEROSCOPE, MODEL 7209208; SMITH & NEPHEW CONTINUOUS FLOW SHEATH, MODEL 8105224 received FDA 510(k) clearance under submission number K013870, sponsored by Smith & Nephew, 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 2002-01-17.
- Submission: K013870
- Applicant / Sponsor: Smith & Nephew, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.1690
- Decision date: 2002-01-17
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.