510(k) K182217
K182217 is an FDA 510(k) premarket notification submitted by Ezisurg (Suzhou) Medical Co., Ltd. for the device "Linear Cutter Staplers and Loading Units for Single Use, Circular Staplers for Single Use". The FDA issued a decision of Substantially Equivalent on Apr 16, 2019. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750. Ezisurg (Suzhou) Medical Co., Ltd. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 16, 2019
- Date Received
- Aug 15, 2018
- 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)