Cleared Traditional

K994191 - SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T

K994191 is an FDA 510(k) clearance for SPETZLER ROUND HANDLE APPLIERS, manufactured by Nmt Medical, Inc.. The device is a Class 2 Neurology device with product code HCI cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K994191 · Nmt Medical, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
57d
Days
Class 2
Risk

K994191 is an FDA 510(k) clearance for the SPETZLER ROUND HANDLE APPLIERS, MODELS C-3753, C-3753T, C-3754, C-3754T. Classified as Applier, Aneurysm Clip (product code HCI), Class II - Special Controls.

Submitted by Nmt Medical, Inc. (Marietta, US). The FDA issued a Cleared decision on February 8, 2000 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4175 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nmt Medical, Inc. devices

FDA 510(k) Submission Details - K994191

510(k) Number K994191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 148d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HCI Device Classification - Class 2, Special Controls

Product Code HCI Applier, Aneurysm Clip
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4175
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - HCI Applier, Aneurysm Clip

All 13
Devices cleared under the same product code (HCI) and FDA review panel - the closest regulatory comparables to K994191.
Aesculap Slim Clip Applier
K180914 · Aesculap, Inc. · Apr 2018
Aesculap Slim Clip Applier Forceps
K173271 · Aesculap, Inc. · Nov 2017
MEDICON YASARGIL CLIP APPLYING FORCEPS
K010910 · Medicon EG · Aug 2001
AESCULAP AXIAL CLIP APPLIER
K984109 · Aesculap, Inc. · Feb 1999
SUNDT SLIM-LINE ANEURYSM CLIP APPLIER
K982379 · Johnson & Johnson Professionals, Inc. · Dec 1998
PERNECZKY CLIP APPLIER/REMOVER
K954658 · Von Zeppelin GmbH · Oct 1996