Cleared Traditional

K896723 - CLIP GUN WITH RANEY TYPE SCALP CLIPS

K896723 is an FDA 510(k) clearance for CLIP GUN WITH RANEY TYPE SCALP CLIPS, manufactured by Omni Medical Designs. The device is a Class 2 Neurology device with product code HBO cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K896723 · Omni Medical Designs · Neurology device
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Mar 1990
Decision
114d
Days
Class 2
Risk

K896723 is an FDA 510(k) clearance for the CLIP GUN WITH RANEY TYPE SCALP CLIPS. Classified as Clip, Scalp (product code HBO), Class II - Special Controls.

Submitted by Omni Medical Designs (Livonia, US). The FDA issued a Cleared decision on March 23, 1990 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4150 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Omni Medical Designs devices

FDA 510(k) Submission Details - K896723

510(k) Number K896723 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 29, 1989
Decision Date March 23, 1990
Days to Decision 114 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
34d faster than avg
Panel avg: 148d · This submission: 114d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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

All 7
Devices cleared under the same product code (HBO) and FDA review panel - the closest regulatory comparables to K896723.
MEDTRONIC CLIP GUN KIT
K050044 · Medtronic Neurosurgery · Feb 2005
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