510(k) K142577
K142577 is an FDA 510(k) premarket notification submitted by B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. for the device "PANTHER Endo Linear Cutter Staplers with Single Use Loading Units". The FDA issued a decision of Substantially Equivalent on Jun 11, 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
- Jun 11, 2015
- Date Received
- Sep 12, 2014
- 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)