Clearance Summary
BYRD TELESCOPING STAINLESS STEEL DILAT SHEATH SET received FDA 510(k) clearance under submission number K922354, sponsored by Med Institute, 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 1992-07-30.
- Submission: K922354
- Applicant / Sponsor: Med Institute, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4200
- Decision date: 1992-07-30
Classification & Regulation
This clearance is catalogued under FDA product code GCC and 21 CFR 878.4200, within the General, Plastic Surgery review panel as a Class I device.