Cleared Special

K012219 - SCALPFIX CLIP SYSTEM

K012219 is an FDA 510(k) clearance for SCALPFIX CLIP SYSTEM, manufactured by Aesculap, Inc.. The device is a Class 2 General & Plastic Surgery device with product code HBO cleared through the Special 510(k) pathway after a 15-day FDA review.

K012219 · Aesculap, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
15d
Days
Class 2
Risk

K012219 is an FDA 510(k) clearance for the SCALPFIX CLIP SYSTEM. Classified as Clip, Scalp (product code HBO), Class II - Special Controls.

Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on July 31, 2001 after a review of 15 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 882.4150 - the FDA general and plastic surgery 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 Aesculap, Inc. devices

FDA 510(k) Submission Details - K012219

510(k) Number K012219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 2001
Decision Date July 31, 2001
Days to Decision 15 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 115d · This submission: 15d
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 General & Plastic Surgery 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 K012219.
Raney Clips Kit
K253814 · Beijing Honghugaoxiang Science and Technology Development CO · Jul 2026
MEDTRONIC CLIP GUN KIT
K050044 · Medtronic Neurosurgery · Feb 2005
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