Cleared Special

K050044 - MEDTRONIC CLIP GUN KIT

K050044 is an FDA 510(k) clearance for MEDTRONIC CLIP GUN KIT, manufactured by Medtronic Neurosurgery. The device is a Class 2 Neurology device with product code HBO cleared through the Special 510(k) pathway after a 28-day FDA review.

K050044 · Medtronic Neurosurgery · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
28d
Days
Class 2
Risk

K050044 is an FDA 510(k) clearance for the MEDTRONIC CLIP GUN KIT. Classified as Clip, Scalp (product code HBO), Class II - Special Controls.

Submitted by Medtronic Neurosurgery (Goleta, US). The FDA issued a Cleared decision on February 7, 2005 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4150 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Medtronic Neurosurgery devices

FDA 510(k) Submission Details - K050044

510(k) Number K050044 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 2005
Decision Date February 07, 2005
Days to Decision 28 days
Submission Type Special
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
120d faster than avg
Panel avg: 148d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

HBO Device Classification - Class 2, Special Controls

Product Code HBO Clip, Scalp
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4150
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 - HBO Clip, Scalp

Devices cleared under the same product code (HBO) and FDA review panel - the closest regulatory comparables to K050044.
Raney Clips Kit
K253814 · Beijing Honghugaoxiang Science and Technology Development CO · Jul 2026
SCALPFIX CLIP SYSTEM
K012219 · Aesculap, Inc. · Jul 2001
CODMAN DISPOSABLE SCALP CLIP APPLIER
K905433 · Codman & Shurtleff, Inc. · Feb 1991
CODMAN RF-12 DISPOSABLE SCALP CLIP APPLIER
K894778 · Codman & Shurtleff, Inc. · Dec 1989
RANEY AND LEROY-RANEY SCALP CLIP
K883963 · New England Surgical Instrument Corp. · Oct 1988
RANEY CLIPS
K881265 · Zimmer, Inc. · May 1988