510(k) K181620
K181620 is an FDA 510(k) premarket notification submitted by Ezisurg (Suzhou) Medical Co., Ltd. for the device "Endoscopic Linear Cutting Staplers and Loading Units for Single Use". The FDA issued a decision of Substantially Equivalent on Sep 18, 2018. 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
- Sep 18, 2018
- Date Received
- Jun 20, 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)