Cleared Traditional

LARYNGOSCOPES RIGID

K822525 · Kelleher Corp. · Ear, Nose, Throat

Sep 1982

Decision

17d

Days

Class 2

Risk

About This 510(k) Submission

K822525 is an FDA 510(k) clearance for the LARYNGOSCOPES RIGID, a Laryngoscope, Nasopharyngoscope (Class II — Special Controls, product code EQN), submitted by Kelleher Corp. (Walker, US). The FDA issued a Cleared decision on September 9, 1982, 17 days after receiving the submission on August 23, 1982. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4760.

Submission Details

510(k) Number	K822525 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 23, 1982
Decision Date	September 09, 1982
Days to Decision	17 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	—

Device Classification

Product Code	EQN — Laryngoscope, Nasopharyngoscope
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 874.4760
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).