Clearance Summary
IRRIGATION SYRINGE KIT received FDA 510(k) clearance under submission number K982435, sponsored by Sub-Q, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1998-11-06.
- Submission: K982435
- Applicant / Sponsor: Sub-Q, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class I
- Regulation citation: 21 CFR 880.6960
- Decision date: 1998-11-06
Classification & Regulation
This clearance is catalogued under FDA product code KYZ and 21 CFR 880.6960, within the General Hospital review panel as a Class I device.