Cleared Traditional

K853589 - SHAH SELF-CLEARING MASTOID SUCTION TUBE
(FDA 510(k) Clearance)

K853589 · Downs Surgical , Ltd. · Ear, Nose, Throat device

Dec 1985

Decision

118d

Days

Class 1

Risk

K853589 is an FDA 510(k) clearance for the SHAH SELF-CLEARING MASTOID SUCTION TUBE. This device is classified as a Tube, Ear Suction (Class I - General Controls, product code JZF).

Submitted by Downs Surgical , Ltd. (Wilmington, US). The FDA issued a Cleared decision on December 23, 1985, 118 days after receiving the submission on August 27, 1985.

This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4420.

Submission Details

510(k) Number	K853589 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 27, 1985
Decision Date	December 23, 1985
Days to Decision	118 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	—