Clearance Summary
VAGINAL RETRACTORS - KRISTELLER, DELEE, BREISKY received FDA 510(k) clearance under submission number K891038, sponsored by Zinnanti Surgical Instruments, 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 1989-03-17.
- Submission: K891038
- Applicant / Sponsor: Zinnanti Surgical Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.4520
- Decision date: 1989-03-17
Classification & Regulation
This clearance is catalogued under FDA product code HDL and 21 CFR 884.4520, within the Obstetrics/Gynecology review panel as a Class I device.