Cleared Traditional

SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T

K994191 · Nmt Medical, Inc. · Neurology
Feb 2000
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K994191 is an FDA 510(k) clearance for the SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T, a Applier, Aneurysm Clip (Class II — Special Controls, product code HCI), submitted by Nmt Medical, Inc. (Marietta, US). The FDA issued a Cleared decision on February 8, 2000, 57 days after receiving the submission on December 13, 1999. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4175.

Submission Details

510(k) Number K994191 FDA.gov
FDA Decision Cleared SESE
Date Received December 13, 1999
Decision Date February 08, 2000
Days to Decision 57 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code HCI — Applier, Aneurysm Clip
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4175