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

Implant, Dermal, For Aesthetic Use In The Hands

Unknown
FDA source (opens on fda.gov)

PKY is the FDA product code for Implant, Dermal, For Aesthetic Use In The Hands, a class III device type. FDA's definition for this code reads: "For hand augmentation to correct volume loss in the dorsum of the hands". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
PKY
Device name
Implant, Dermal, For Aesthetic Use In The Hands
FDA definition
For hand augmentation to correct volume loss in the dorsum of the hands.
Device class
Class III
Review panel
Unknown
Submission type
PMA
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order