510(k) K123066
K123066 is an FDA 510(k) premarket notification submitted by Covidien, LLC for the device "ACCUMESH DEPLOYMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on October 16, 2012. The device falls under product code ORQ (Mesh, Surgical, Deployer), a Class II device regulated under 21 CFR 878.3300. Covidien, LLC has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 16, 2012
- Date Received
- October 1, 2012
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mesh, Surgical, Deployer
- Device Class
- Class II
- Regulation Number
- 878.3300
- Review Panel
- SU
- Submission Type
Intended to be used to facilitate the delivery of soft tissue prosthetics during the laparoscopic repair of soft tissue defects (e.G. Hernia repair).