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

Knife, Surgical

21 CFR 878.4800 / General, Plastic Surgery
FDA source (opens on fda.gov)

EMF is the FDA product code for Knife, Surgical, a class I device type, regulated under 21 CFR 878.4800. As of , FDA records hold 21 510(k) clearances under this code, the most recent dated , and 9 recalls.

Classification record

Product code
EMF
Device name
Knife, Surgical
Regulation
21 CFR 878.4800
Device class
Class I
Review panel
General, Plastic Surgery
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
21
Ingested recalls
9

Clearances, product code EMF

By decision year
21 clearances under product code EMF with a decision year between 1978 and 2008, 1984 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code EMF by decision year
YearClearances
19782
19791
19801
19821
19831
19844
19851
19864
19881
19893
19981
20081

Applicants with the most clearances

Product code EMF
Applicants holding the most 510(k) clearances under product code EMF
ApplicantClearances
Kinetic Medical Products3
A.M. Surgical, Inc.2
Imm Enterprises, Ltd.2
Nestor Engineering Associates, Inc.2
Artiberia1
Biological & Environmental Control Laboratories1
Davis & Geck, Inc.1
Devon Industries, Inc.1
Downs Surgical, Ltd.1
Eder Instrument Co, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 209 companies shown, in name order