Clearance Summary
SIGMA 1 WOBBLER BIOPSY KIT received FDA 510(k) clearance under submission number K882673, sponsored by Kontron Instruments, Inc.. 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 1988-07-28.
- Submission: K882673
- Applicant / Sponsor: Kontron Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.4730
- Decision date: 1988-07-28
Classification & Regulation
This clearance is catalogued under FDA product code FCH and 21 CFR 876.4730, within the Gastroenterology, Urology review panel as a Class I device.