Forceps, Biopsy, Bronchoscope (Rigid)

FDA product code JEK · Class II (moderate risk) · 21 CFR 874.4680 · Ear, Nose, Throat

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).

3510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K990561Optical ForcepsJEK · Traditional Pilling Weck Surgical05/14/1999SE
K822198Malleus NippersJEK · Traditional Kelleher Corp.08/25/1982SE
K822193Forceps for Use with Rigid EndoscopesJEK · Traditional Kelleher Corp.08/24/1982SE