DeviceClearance

Product code OBK— General Hospital

FOAM RING PORT PROTECTOR

Classification name
Port, Protector/Cushion
Device class
Class 2
Regulation
21 CFR 880.5965
Advisory panel
General Hospital
Total cleared
1
First cleared
Most recent

FDA classification definition

“Intended to cushion and protect the localized area surrounding the implanted port and indicated for subjects having implanted subcutaneous or intravascular infusion ports.”

— U.S. Food and Drug Administration, device classification record for product code OBK under 21 CFR 880.5965, via openFDA

Market context for product code OBK

FDA has cleared 1 device under product code OBK, all in 2007, filed by 1 applicant company. 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.

Top applicants under product code OBK

Recent clearances under product code OBK

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