Clearance Summary
MODIFIED METAL SPECULUM & SPECIAL BULLET FORCEPS received FDA 510(k) clearance under submission number K902019, sponsored by Gynescope Corp.. 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 1990-06-07.
- Submission: K902019
- Applicant / Sponsor: Gynescope Corp.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.4520
- Decision date: 1990-06-07
Classification & Regulation
This clearance is catalogued under FDA product code HDF and 21 CFR 884.4520, within the Obstetrics/Gynecology review panel as a Class I device.