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

Device For Sealing Microsections

21 CFR 864.3400 / Pathology
FDA source (opens on fda.gov)

KIM is the FDA product code for Device For Sealing Microsections, a class I device type, regulated under 21 CFR 864.3400. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and one recall.

Classification record

Product code
KIM
Device name
Device For Sealing Microsections
Regulation
21 CFR 864.3400
Device class
Class I
Review panel
Pathology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
1

Clearances, product code KIM

By decision year
1 clearance under product code KIM with a decision year between 1978 and 1978, 1978 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KIM by decision year
YearClearances
19781

Applicants with the most clearances

Product code KIM
Applicants holding the most 510(k) clearances under product code KIM
ApplicantClearances
Shandon, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code