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

Transurethral Occlusion Insert, Urinary Incontinence-Control, Female

Unknown
FDA source (opens on fda.gov)

OCK is the FDA product code for Transurethral Occlusion Insert, Urinary Incontinence-Control, Female, a class III device type. FDA's definition for this code reads: "Transurethral insert for urinary occlusion/control in women with urinary incontinence". As of , FDA records hold no 510(k) clearances under this code and 8 recalls.

Classification record

Product code
OCK
Device name
Transurethral Occlusion Insert, Urinary Incontinence-Control, Female
FDA definition
Transurethral insert for urinary occlusion/control in women with urinary incontinence
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
8

Companies listing this code with FDA

Companies whose registered establishments list this code

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