Clearance Summary
JAKOBI SURGICAL INSTRUMENTS #3 17/18/19 received FDA 510(k) clearance under submission number K834191, sponsored by Imm Enterprises , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1984-03-22.
- Submission: K834191
- Applicant / Sponsor: Imm Enterprises , Ltd.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.4730
- Decision date: 1984-03-22
Classification & Regulation
This clearance is catalogued under FDA product code KOA and 21 CFR 876.4730, within the Gastroenterology, Urology review panel as a Class I device.