Cleared Special

K102768 - SECRMARK BIOPSY SITE MARKING SYSTEM

K102768 is an FDA 510(k) clearance for SECRMARK BIOPSY SITE MARKING SYSTEM, manufactured by Hologic, Inc.. The device is a Class 2 General & Plastic Surgery device with product code NEU cleared through the Special 510(k) pathway after a 69-day FDA review.

K102768 · Hologic, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
69d
Days
Class 2
Risk

K102768 is an FDA 510(k) clearance for the SECRMARK BIOPSY SITE MARKING SYSTEM. Classified as Marker, Radiographic, Implantable (product code NEU), Class II - Special Controls.

Submitted by Hologic, Inc. (Indianapolis, US). The FDA issued a Cleared decision on December 2, 2010 after a review of 69 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 - K102768

510(k) Number K102768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2010
Decision Date December 02, 2010
Days to Decision 69 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
46d faster than avg
Panel avg: 115d · This submission: 69d
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 K102768.
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K102608 · Suros Surgical Systems, Inc. A Hologic Company · Oct 2010
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PRELOADED TISSUE MARKER DEVICE
K100994 · Carbon Medical Technologies, Inc. · Apr 2010
K102768 · SECRMARK BIOPSY SITE MARKING SYSTEM
Download PDF FDA Summary Hologic, Inc.