510(k) K120179
K120179 is an FDA 510(k) premarket notification submitted by Reach Surgical, Inc. for the device "REACH SURGICAL STAPLERS". The FDA issued a decision of Substantially Equivalent on May 23, 2012. 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
- May 23, 2012
- Date Received
- Jan 20, 2012
- 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)