Clearance Summary
TISSUE SECTION ADHESIVE received FDA 510(k) clearance under submission number K881659, sponsored by Surgipath Medical Industries, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 1988-04-21.
- Submission: K881659
- Applicant / Sponsor: Surgipath Medical Industries, Inc.
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class I
- Regulation citation: 21 CFR 864.4010
- Decision date: 1988-04-21
Classification & Regulation
This clearance is catalogued under FDA product code IFZ and 21 CFR 864.4010, within the Pathology review panel as a Class I device.