Cleared Traditional

K890443 - CASPAR SCALP CLIP, APPLIER

K890443 is an FDA 510(k) clearance for CASPAR SCALP CLIP, manufactured by Aesculap Instruments Corp.. The device is a Class 2 Neurology device with product code HBO cleared through the Traditional 510(k) pathway after a 139-day FDA review.

K890443 · Aesculap Instruments Corp. · Neurology device
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Jun 1989
Decision
139d
Days
Class 2
Risk

K890443 is an FDA 510(k) clearance for the CASPAR SCALP CLIP, APPLIER. Classified as Clip, Scalp (product code HBO), Class II - Special Controls.

Submitted by Aesculap Instruments Corp. (Burlingame, US). The FDA issued a Cleared decision on June 15, 1989 after a review of 139 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 Aesculap Instruments Corp. devices

FDA 510(k) Submission Details - K890443

510(k) Number K890443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1989
Decision Date June 15, 1989
Days to Decision 139 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 148d · This submission: 139d
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 K890443.
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