Clearance Summary
THE EMMETT IUD THREAD RETRIEVER received FDA 510(k) clearance under submission number K811761, sponsored by Proto-Med, 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 1981-09-21.
- Submission: K811761
- Applicant / Sponsor: Proto-Med, Inc.
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class I
- Regulation citation: 21 CFR 884.4530
- Decision date: 1981-09-21
Classification & Regulation
This clearance is catalogued under FDA product code HHF and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class I device.