510(k) K122263
K122263 is an FDA 510(k) premarket notification submitted by Symmetry Medical for the device "14.5-16.0 FRENCH CUFFED CATHETER REMOVAL DEVICE, SYMMETRY SURGICAL SINGEL USE". The FDA issued a decision of Substantially Equivalent on September 28, 2012. The device falls under product code ODY (Tunneled Catheter Remover), a Class II device regulated under 21 CFR 880.5970. Symmetry Medical has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 28, 2012
- Date Received
- July 27, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tunneled Catheter Remover
- Device Class
- Class II
- Regulation Number
- 880.5970
- Review Panel
- HO
- Submission Type
To assist in the removal of tunneled long term catheter cuffs using a minimal invasive technique by seperating the tissue ingrowth cuff from the surrounding tissue. Following seperation of the cuff from the tissue, the catheter can be safely removed from the body.