JEK — Forceps, Biopsy, Bronchoscope (Rigid) Class II

FDA Device Classification

Classification Details

Product Code: JEK
Device Class: Class II
Regulation Number: 874.4680
Submission Type
Review Panel: EN
Medical Specialty: Ear, Nose, Throat
Implant: No

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).

Recent 510(k) Clearances

K-Number	Applicant	Device Name	Date
K990561	pilling weck surgical	OPTICAL FORCEPS	May 14, 1999
K822198	kelleher	MALLEUS NIPPERS	August 25, 1982
K822193	kelleher	FORCEPS FOR USE WITH RIGID ENDOSCOPES	August 24, 1982