FDA Product Code JEK: Forceps, Biopsy, Bronchoscope (rigid)
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).
Leading manufacturers include Kelleher Corp. and Pilling Weck Surgical.
3
Total
3
Cleared
49d
Avg days
1982
Since
FDA 510(k) Cleared Forceps, Biopsy, Bronchoscope (rigid) Devices (Product Code JEK)
3 devices
Cleared
May 14, 1999
OPTICAL FORCEPS
Pilling Weck Surgical
Ear, Nose, Throat
81d
Cleared
Aug 25, 1982
MALLEUS NIPPERS
Kelleher Corp.
Ear, Nose, Throat
33d
Cleared
Aug 24, 1982
FORCEPS FOR USE WITH RIGID ENDOSCOPES
Kelleher Corp.
Ear, Nose, Throat
32d