Cleared Special

K090547 - ULTRACLIP II US WING AND COIL

K090547 is the FDA 510(k) clearance for ULTRACLIP II US WING AND COIL by C.R. Bard, Inc.. It is a Class 2 General & Plastic Surgery device (product code NEU) cleared through the Special 510(k) pathway after a 16-day FDA review.

K090547 · C.R. Bard, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
16d
Days
Class 2
Risk

K090547 is an FDA 510(k) clearance for the ULTRACLIP II US WING AND COIL, MODELS: 862017U, 864017U. Classified as Marker, Radiographic, Implantable (product code NEU), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Tempe, US). The FDA issued a Cleared decision on March 18, 2009 after a review of 16 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4300 - 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K090547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2009
Decision Date March 18, 2009
Days to Decision 16 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
99d faster than avg
Panel avg: 115d · This submission: 16d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NEU Marker, Radiographic, Implantable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4300
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 - NEU Marker, Radiographic, Implantable

All 55
Devices cleared under the same product code (NEU) and FDA review panel - the closest regulatory comparables to K090547.
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K053518 · Medical Device Technologies, Inc. · Jan 2006
INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR
K051421 · Medical Device Technologies, Inc. · Aug 2005
MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS
K040990 · Walter Lorenz Surgical, Inc. · May 2004