Cleared Traditional

ENDOSCOPES FOR SINUS SURGERY

K874215 · Richards Medical Co., Inc. · Ear, Nose, Throat

Jan 1988

Decision

80d

Days

Class 2

Risk

About This 510(k) Submission

K874215 is an FDA 510(k) clearance for the ENDOSCOPES FOR SINUS SURGERY, a Nasopharyngoscope (flexible Or Rigid) (Class II — Special Controls, product code EOB), submitted by Richards Medical Co., Inc. (Memphus, US). The FDA issued a Cleared decision on January 4, 1988, 80 days after receiving the submission on October 16, 1987. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.4760.

Submission Details

510(k) Number	K874215 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 16, 1987
Decision Date	January 04, 1988
Days to Decision	80 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	—

Device Classification

Product Code	EOB — Nasopharyngoscope (flexible Or Rigid)
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).