510(k) K152618
K152618 is an FDA 510(k) premarket notification submitted by B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. for the device "PANTHER Cutter Stapler". The FDA issued a decision of Substantially Equivalent on Nov 12, 2015. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750. B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 12, 2015
- Date Received
- Sep 14, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Staple, Implantable
- Device Class
- Class II
- Regulation Number
- 878.4750
- Review Panel
- SU
- Submission Type
- 510(k)