Cleared Special

K993265 - SORING GMBH, ARCO 3000, ARCO 2000, ARCO 1000, MBC 601, MBC 600

K993265 is an FDA 510(k) clearance for 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 23-day FDA review.

K993265 · Soring GmbH Medizintechnik · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1999
Decision
23d
Days
Class 2
Risk

K993265 is an FDA 510(k) clearance for the SORING GMBH, ARCO 3000, ARCO 2000, ARCO 1000, MBC 601, MBC 600. 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 (Cincinnati, US). The FDA issued a Cleared decision on October 22, 1999 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 Soring GmbH Medizintechnik devices

FDA 510(k) Submission Details - K993265

510(k) Number K993265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1999
Decision Date October 22, 1999
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 1485
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K993265.
XOMED ENT RF SYSTEM
K993112 · Xomed, Inc. · Dec 1999
ORA-50 S AUTOTEMP ELECTROTHERMAL SPINE SYSTEM AND ACCESSORIES
K993854 · Oratec Interventions, Inc. · Dec 1999
ORATEC INTERVENTIONS VULCAN EAS ELECTROTHERMAL ARTHROSCOPY SYSTEM AND ACCESSORIES
K991140 · Oratec Interventions, Inc. · Oct 1999
ERBE APC RASPATORY HANDLE AND TIP, MODEL 20132-102, 20132-103
K992764 · Erbe USA, Inc. · Oct 1999
ERBE APC APPLICATORS, MODELS 20132-106, 20132-107, 20132-109, 20132-110, 20132-11, 20132-112,20132-113, 20132-114, 2013-
K992769 · Erbe USA, Inc. · Oct 1999
DYONICS VARICOSE VEIN ABLATION BLADE
K990723 · Smith & Nephew, Inc. · Oct 1999