Cleared Special

K080698 - GEL MARK ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGP

K080698 is an FDA 510(k) clearance for GEL MARK ULTRACOR BIOPSY SITE MARKER, manufactured by Senorx, Inc.. The device is a Class 2 General & Plastic Surgery device with product code NEU cleared through the Special 510(k) pathway after a 19-day FDA review.

K080698 · Senorx, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
19d
Days
Class 2
Risk

K080698 is an FDA 510(k) clearance for the GEL MARK ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGP. Classified as Marker, Radiographic, Implantable (product code NEU), Class II - Special Controls.

Submitted by Senorx, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on March 31, 2008 after a review of 19 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.

FDA 510(k) Submission Details - K080698

510(k) Number K080698 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 12, 2008
Decision Date March 31, 2008
Days to Decision 19 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
96d faster than avg
Panel avg: 115d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

NEU Device Classification - Class 2, Special Controls

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 109
Devices cleared under the same product code (NEU) and FDA review panel - the closest regulatory comparables to K080698.
MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS
K082278 · Ethicon Endo-Sugery, LLC · Dec 2008
STARCHMARK BIOPSY SITE MARKER, MODEL STMKEC-10GSS, STMKEC-10GTR, STMKMT-11GS
K081085 · Senorx, Inc. · Aug 2008
PROSTATE TISSUE MARKER
K081170 · Senorx, Inc. · May 2008
TUMARK PROFESSIONAL, MODEL 271560
K073095 · Somatex Medical Technologies GmbH · Mar 2008
CYTOPHIL TISSUE MARKER
K072219 · Cytophil, Inc. · Jan 2008
SECURMARK BIOPSY SITE IDENTIFICATION SYSTEM
K072913 · Suros Surgical Systems, Inc. A Hologic Company · Jan 2008
K080698 · GEL MARK ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGP
Download PDF FDA Summary Senorx, Inc.