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

System, Documentation, Breast Lesion

21 CFR 884.2990 / Obstetrics/Gynecology
FDA source (opens on fda.gov)

NKA is the FDA product code for System, Documentation, Breast Lesion, a class II device type, regulated under 21 CFR 884.2990. FDA's definition for this code reads: "A Breast lesion documentation device is a device for recording and documenting palpable breast lesions detected during a clinical breast exam". As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NKA
Device name
System, Documentation, Breast Lesion
FDA definition
A Breast lesion documentation device is a device for recording and documenting palpable breast lesions detected during a clinical breast exam.
Regulation
21 CFR 884.2990
Device class
Class II
Review panel
Obstetrics/Gynecology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
0

Clearances, product code NKA

By decision year
4 clearances under product code NKA with a decision year between 2003 and 2019, 2019 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code NKA by decision year
YearClearances
20031
20151
20192

Applicants with the most clearances

Product code NKA
Applicants holding the most 510(k) clearances under product code NKA
ApplicantClearances
UE Lifesciences Inc.2
Assurance Medical1
Sure, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code