Cleared Traditional

GIBSON ENDOLYMPHATIC SHUNT

K897049 · Hood Laboratories · Ear, Nose, Throat
Mar 1990
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K897049 is an FDA 510(k) clearance for the GIBSON ENDOLYMPHATIC SHUNT, a Tube, Shunt, Endolymphatic (Class II — Special Controls, product code ESZ), submitted by Hood Laboratories (Pembroke, US). The FDA issued a Cleared decision on March 16, 1990, 88 days after receiving the submission on December 18, 1989. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 874.3820.

Submission Details

510(k) Number K897049 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 1989
Decision Date March 16, 1990
Days to Decision 88 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary —

Device Classification

Product Code ESZ — Tube, Shunt, Endolymphatic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 874.3820