Cleared Special

K052506 - RUBICOR ENCAPSULE BREAST BIOPSY DEVICE

K052506 is an FDA 510(k) clearance for RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, manufactured by Rubicor Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Special 510(k) pathway after a 23-day FDA review.

K052506 · Rubicor Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2005
Decision
23d
Days
Class 2
Risk

K052506 is an FDA 510(k) clearance for the RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 31108. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Rubicor Medical, Inc. (San Carlos, US). The FDA issued a Cleared decision on October 6, 2005 after a review of 23 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - 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 Rubicor Medical, Inc. devices

FDA 510(k) Submission Details - K052506

510(k) Number K052506 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2005
Decision Date October 06, 2005
Days to Decision 23 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 115d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

GEI Device Classification - Class 2, Special Controls

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 1202
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K052506.
ELECTROSURGICAL GENERATOR SYSTEM, MODEL ES 3000
K052857 · Senorx, Inc. · Oct 2005
CADMAN INTEGRATED IRRIGATION TUBING AND BIPOLAR CORD SET, MODELS 80-1163, 80-1189
K052449 · Codman & Shurtleff, Inc. · Oct 2005
STRYKER STILETTO ELECTROSURGICAL PROBE
K052141 · Stryker Endoscopy · Oct 2005
ARTHROCARE ARTHROWANDS
K052686 · Arthrocare Corp. · Oct 2005
CONMED SYSTEM MODEL 2450 ELECTROSURGICAL GENERATOR
K052009 · Conmed Corporation · Sep 2005
SMITH & NEPHEW VULCAN ARTICULAR CARTILAGE PROBE, MODEL 721XXXX
K050898 · Smith & Nephew, Inc. · May 2005