Clearance Summary
FORCEPS, BIOPSY GYNECOLOGICAL INSTRU/BIOPSY received FDA 510(k) clearance under submission number K933767, sponsored by Mahe-Medizintechnik. 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 1994-05-26.
- Submission: K933767
- Applicant / Sponsor: Mahe-Medizintechnik
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.4530
- Decision date: 1994-05-26
Classification & Regulation
This clearance is catalogued under FDA product code HFB and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class I device.