510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OBKClass II

Port, Protector/Cushion

21 CFR 880.5965 / General Hospital
FDA source (opens on fda.gov)

OBK is the FDA product code for Port, Protector/Cushion, a class II device type, regulated under 21 CFR 880.5965. FDA's definition for this code reads: "Intended to cushion and protect the localized area surrounding the implanted port and indicated for subjects having implanted subcutaneous or intravascular infusion ports". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and one recall.

Classification record

Product code
OBK
Device name
Port, Protector/Cushion
FDA definition
Intended to cushion and protect the localized area surrounding the implanted port and indicated for subjects having implanted subcutaneous or intravascular infusion ports.
Regulation
21 CFR 880.5965
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
1

Clearances, product code OBK

By decision year
1 clearance under product code OBK with a decision year between 2007 and 2007, 2007 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code OBK by decision year
YearClearances
20071

Applicants with the most clearances

Product code OBK
Applicants holding the most 510(k) clearances under product code OBK
ApplicantClearances
Inspired Ideas, Incorporated1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code OBK.