Clearance Summary
BIOMER * PLEDGET SUTURE BUTTRESS received FDA 510(k) clearance under submission number K832138, sponsored by ETHICON, 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 1984-05-23.
- Submission: K832138
- Applicant / Sponsor: ETHICON, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4930
- Decision date: 1984-05-23
Classification & Regulation
This clearance is catalogued under FDA product code KGS and 21 CFR 878.4930, within the General, Plastic Surgery review panel as a Class I device.