Cleared Special

K030049 - MODIFICATION TO RUBICOR ENCAPSULE BREAS...

K030049 is an FDA 510(k) clearance for MODIFICATION TO RUBICOR ENCAPSULE BREAS..., 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.

K030049 · Rubicor Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2003
Decision
23d
Days
Class 2
Risk

K030049 is an FDA 510(k) clearance for the MODIFICATION TO RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086. 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 January 29, 2003 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 - K030049

510(k) Number K030049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 06, 2003
Decision Date January 29, 2003
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 K030049.
AUTOCON II 200 ELECTROSURGICAL GENERATOR
K023924 · Karl Storz Endoscopy · Feb 2003
BOVIE IDS-300 HIGH FREQUENCY ELECTROSURGICAL GENERATOR
K022856 · Aaron Medical Industries · Feb 2003
ARTHROCARE ENT COBLATOR SURGERY SYSTEM
K030108 · Arthrocare Corp. · Feb 2003
BIPOLAR FORCEPS
K023813 · Richard Wolf Medical Instruments Corp. · Jan 2003
ERBE VIO APC WITH ACCESSORIES
K024047 · Erbe USA, Inc. · Jan 2003
ARTHREX OPES ELECTRODES AND ACCESSORIES
K023986 · Arthrex, Inc. · Dec 2002