Cleared Traditional

K982379 - SUNDT SLIM-LINE ANEURYSM CLIP APPLIER
(FDA 510(k) Clearance)

K982379 · Johnson & Johnson Professionals, Inc. · Neurology

Dec 1998

Decision

163d

Days

Class 2

Risk

K982379 is an FDA 510(k) clearance for the SUNDT SLIM-LINE ANEURYSM CLIP APPLIER. This device is classified as a Applier, Aneurysm Clip (Class II — Special Controls, product code HCI).

Submitted by Johnson & Johnson Professionals, Inc. (Raynham, US). The FDA issued a Cleared decision on December 18, 1998, 163 days after receiving the submission on July 8, 1998.

This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.4175.

Submission Details

510(k) Number	K982379 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 08, 1998
Decision Date	December 18, 1998
Days to Decision	163 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF