Clearance Summary
APPOSE UNITY STERILE DISPOSABLE SKIN STAPLER received FDA 510(k) clearance under submission number K900486, sponsored by Davis & Geck, 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 1990-04-20.
- Submission: K900486
- Applicant / Sponsor: Davis & Geck, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4760
- Decision date: 1990-04-20
Classification & Regulation
This clearance is catalogued under FDA product code GDT and 21 CFR 878.4760, within the General, Plastic Surgery review panel as a Class I device.