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

Neurosurgical Ultrasonic Instruments

Unknown
FDA source (opens on fda.gov)

LBK is the FDA product code for Neurosurgical Ultrasonic Instruments. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
LBK
Device name
Neurosurgical Ultrasonic Instruments
Device class
Unclassified
Review panel
Unknown
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
7
Ingested recalls
1

Clearances, product code LBK

By decision year
7 clearances under product code LBK with a decision year between 1985 and 1997, 1988 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code LBK by decision year
YearClearances
19851
19861
19883
19961
19971

Applicants with the most clearances

Product code LBK
Applicants holding the most 510(k) clearances under product code LBK
ApplicantClearances
Medtronic, Inc.2
Amerimed US Corp.1
Clinical Technology Inc.1
Cooper Lasersonics, Inc.1
Olympus Optical Co., Ltd.1
Satelec1

Companies listing this code with FDA

Companies whose registered establishments list this code