Clearance Summary
APPOSE ULTRA DISPOS. SKIN STAPLER W/AUTO RELEASE received FDA 510(k) clearance under submission number K844417, sponsored by Davis & Geck, 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 1984-12-17.
- Submission: K844417
- Applicant / Sponsor: Davis & Geck, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 878.4740
- Decision date: 1984-12-17
Classification & Regulation
This clearance is catalogued under FDA product code GAG and 21 CFR 878.4740, within the General Hospital review panel as a Class II device.