Clearance Summary
PANPAC WORD/BARTHOLIN CATHETER received FDA 510(k) clearance under submission number K130087, sponsored by Panpac Medical Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Obstetrics/Gynecology review panel. The statutory decision date of record is 2014-01-10.
- Submission: K130087
- Applicant / Sponsor: Panpac Medical Corporation
- Clearance pathway: Traditional
- Review panel: Obstetrics/Gynecology
- Device class: Class II
- Regulation citation: 21 CFR 884.4530
- Decision date: 2014-01-10
Classification & Regulation
This clearance is catalogued under FDA product code KNA and 21 CFR 884.4530, within the Obstetrics/Gynecology review panel as a Class II device.