Cleared Special

K030028 - CPC BY SORING GMBH

K030028 is an FDA 510(k) clearance for CPC BY SORING GMBH, manufactured by Soring GmbH Medizintechnik. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Special 510(k) pathway after a 14-day FDA review.

K030028 · Soring GmbH Medizintechnik · General & Plastic Surgery device
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Jan 2003
Decision
14d
Days
Class 2
Risk

K030028 is an FDA 510(k) clearance for the CPC BY SORING GMBH. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Soring GmbH Medizintechnik (Denton, US). The FDA issued a Cleared decision on January 17, 2003 after a review of 14 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 Soring GmbH Medizintechnik devices

FDA 510(k) Submission Details - K030028

510(k) Number K030028 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2003
Decision Date January 17, 2003
Days to Decision 14 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
101d faster than avg
Panel avg: 115d · This submission: 14d
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 1485
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K030028.
ARTHROCARE ENT COBLATOR SURGERY SYSTEM
K030108 · Arthrocare Corp. · Feb 2003
THERMACOOL TC SYSTEM
K030142 · Thermage, Inc. · Feb 2003
BIPOLAR FORCEPS
K023813 · Richard Wolf Medical Instruments Corp. · Jan 2003
AURA 20 BIPOLAR ELECTROSURGICAL COAGULATOR, MODEL 26-2500
K023482 · Kirwan Surgical Products, Inc. · Jan 2003
ERBE VIO APC WITH ACCESSORIES
K024047 · Erbe USA, Inc. · Jan 2003
OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ITS ASSOCIATED ACCESSORIES
K023280 · Olympus Optical Co., Ltd. · Dec 2002