Clearance Summary
NEWPORT LATERAL VAGINAL RETRACTOR received FDA 510(k) clearance under submission number K891351, sponsored by Simpson/Basye, 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 1989-05-11.
- Submission: K891351
- Applicant / Sponsor: Simpson/Basye, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.4520
- Decision date: 1989-05-11
Classification & Regulation
This clearance is catalogued under FDA product code KOH and 21 CFR 884.4520, within the Obstetrics/Gynecology review panel as a Class I device.