510(k) K101218
K101218 is an FDA 510(k) premarket notification submitted by Polytouch Medical, Ltd. for the device "PATCHASSIST". The FDA issued a decision of Substantially Equivalent on June 17, 2010. The device falls under product code ORQ (Mesh, Surgical, Deployer), a Class II device regulated under 21 CFR 878.3300. Polytouch Medical, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 17, 2010
- Date Received
- April 30, 2010
- Clearance Type
- Traditional
- 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).