510(k) K192566
K192566 is an FDA 510(k) premarket notification submitted by Reach Surgical, Inc. for the device "Reach and CQ'ENCE Circular Staplers". The FDA issued a decision of Substantially Equivalent on Oct 17, 2019. The device falls under product code GDW (Staple, Implantable), a Class II device regulated under 21 CFR 878.4750. Reach Surgical, Inc. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 17, 2019
- Date Received
- Sep 18, 2019
- Clearance Type
- Special
- 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)