Laryngoscope, Nasopharyngoscope

FDA product code EQN · Class II (moderate risk) · 21 CFR 874.4760 · 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).

22510(k) clearances
0PMA approvals
2recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K252624KARL STORZ Laryngoscopes and AccessoriesEQN · Traditional KARL STORZ Endoscopy-America, Inc.05/15/2026SE
K150248ORL Video NasoPharyngo-LarngoscopeEQN · Traditional Jedmed Instrument Company07/23/2015SE
K132039Ergo-Flex Laryngo-Nasopharyngoscope Ef-N and Ef-N SlimEQN · Traditional Jedmed Instrument Co.02/21/2014SE
K834172Op-Con Surg. Instrument #7EQN · Traditional Imm Enterprises , Ltd.03/06/1984SE
K831255Laryngoscope Attachment PH2000EQN · Traditional Eder Instrument Co, Inc.09/12/1983SE
K830888Cool-Lite Fibercoptic Laryngeal ExamEQN · Traditional National Medical Technology04/27/1983SE
K822525Laryngoscopes RigidEQN · Traditional Kelleher Corp.09/09/1982SE
K821710Nagashima NX-150F Light Source UnitEQN · Traditional Kelleher Corp.06/25/1982SE
K821709Nagashima Light Source Unit SL-5EQN · Traditional Kelleher Corp.06/25/1982SE
K821708Nagashima Light Source Unit SL-4EQN · Traditional Kelleher Corp.06/25/1982SE
K821707Nagashima Sft-Ii Laryngoscope StraightEQN · Traditional Kelleher Corp.06/25/1982SE
K821706Nagashima Sft-I Laryngoscope Right-AnglEQN · Traditional Kelleher Corp.06/25/1982SE
K821269Tracheostomy Care TraysEQN · Traditional Intermed, Inc.05/27/1982SE
K821182Model ENT-4L-FLEXIBLE Nasopharyngo-EQN · Traditional Machida America, Inc.05/13/1982SE
K821181Flexible Nasopharyngo-Laryngoscope #EQN · Traditional Machida America, Inc.05/13/1982SE
K813297Conphar LaryngoscopeEQN · Traditional Conphar, Inc.01/22/1982SE
K812734Machida Flexible Intubation Scope Fls-PEQN · Traditional Machida America, Inc.10/19/1981SE
K811943Machida Nasopharyngo-LaryngoscopeEQN · Traditional Machida America, Inc.07/28/1981SE
K792222Shiley Low Pressure Thin-Cuffed Trach.EQN · Traditional Shiley, Inc.12/18/1979SE
K782002Trach-CollarEQN · Traditional Kinetic Concepts, Inc.12/15/1978SE
K781639Shiley Cricothyrotomy TubeEQN · Traditional Shiley, Inc.10/24/1978SE
K770085Robbett Microsurgical LaryngoscopeEQN · Traditional Edward Weck, Inc.01/21/1977SE

Recalls

RecallProductFirmInitiated
Z-1618-2020 Class IIKarl Storz SE & Co. KG, C-MAC Video Laryngoscope MIL # 1, for the following REF numbers:…The firm has become aware that there is a potential that the glass cover at the distal end of the camera/led… Karl Storz Endoscopy12/06/2019Terminated
Z-1488-2012 BOMImed Reusable Integrated Fiber Optic Laryngoscope Blades, MacIntosh and Miller styles…On 9/1/2010 BOMImed, Inc. Winnipeg, MB, Canada initiated a recall of their BOMImed Integrated Reusable… Bomimed Inc12/08/2010Terminated