DeviceClearance

Product code ODY— General Hospital

14.5-16.0 FRENCH CUFFED CATHETER REMOVAL DEVICE, SYMMETRY SURGICAL SINGEL USE

Classification name
Tunneled Catheter Remover
Device class
Class 2
Regulation
21 CFR 880.5970
Advisory panel
General Hospital
Total cleared
2
First cleared
Most recent

FDA classification definition

“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.”

— U.S. Food and Drug Administration, device classification record for product code ODY under 21 CFR 880.5970, via openFDA

Market context for product code ODY

FDA has cleared 2 devices under product code ODY between 2007 and 2012, filed by 2 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code ODY

Recent clearances under product code ODY

Data sourced from openFDA. This site is unofficial and independent of the FDA.