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

Forceps, Biopsy, Bronchoscope (Rigid)

21 CFR 874.4680 / Ear, Nose, Throat
FDA source (opens on fda.gov)

JEK is the FDA product code for Forceps, Biopsy, Bronchoscope (Rigid), a class II device type, regulated under 21 CFR 874.4680. FDA's definition for this code reads: "If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf)". As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
JEK
Device name
Forceps, Biopsy, Bronchoscope (Rigid)
FDA definition
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Regulation
21 CFR 874.4680
Device class
Class II
Review panel
Ear, Nose, Throat
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code JEK

By decision year
3 clearances under product code JEK with a decision year between 1982 and 1999, 1982 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code JEK by decision year
YearClearances
19822
19991

Applicants with the most clearances

Product code JEK
Applicants holding the most 510(k) clearances under product code JEK
ApplicantClearances
Kelleher Corp.2
Pilling Weck Surgical1

Companies listing this code with FDA

Companies whose registered establishments list this code