Clearance Summary
PANTHER GROUP OF SURGICAL INCLUDES: OANTHER CIRCULAR STAPLER; PANTHER HEMORRHOIDAL CIRCULAR STAPLER; PANTHER LINEAR STAP received FDA 510(k) clearance under submission number K103470, sponsored by B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.. 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 2011-01-11.
- Submission: K103470
- Applicant / Sponsor: B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class II
- Regulation citation: 21 CFR 878.4750
- Decision date: 2011-01-11
Classification & Regulation
This clearance is catalogued under FDA product code GDW and 21 CFR 878.4750, within the General, Plastic Surgery review panel as a Class II device.