Clearance Summary
INTELIJET SUCTION SUPPLY received FDA 510(k) clearance under submission number K922176, sponsored by Smith & Nephew Dyonics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1992-11-18.
- Submission: K922176
- Applicant / Sponsor: Smith & Nephew Dyonics, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4780
- Decision date: 1992-11-18
Classification & Regulation
This clearance is catalogued under FDA product code BTA and 21 CFR 878.4780, within the General, Plastic Surgery review panel as a Class II device.