Clearance Summary
BIOGEL (R) INDICATOR (R) UNDERGLOVE received FDA 510(k) clearance under submission number K111413, sponsored by Molnlycke Health Care Us, LLC. The device was reviewed via the Special premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2012-01-30.
- Submission: K111413
- Applicant / Sponsor: Molnlycke Health Care Us, LLC
- Clearance pathway: Special
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4460
- Decision date: 2012-01-30
Classification & Regulation
This clearance is catalogued under FDA product code KGO and 21 CFR 878.4460, within the General, Plastic Surgery review panel as a Class I device.