Cleared Special

K050161 - SYSTEM 7500-B ELECTROSURGICAL UNIT

Also marketed or referenced as:
ABCFLEX PROBE FOR FLEXIBLE ENDOSCOPY

K050161 is an FDA 510(k) clearance for SYSTEM 7500-B ELECTROSURGICAL UNIT, manufactured by Conmed Electrosurgery. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Special 510(k) pathway after a 9-day FDA review.

K050161 · Conmed Electrosurgery · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
9d
Days
Class 2
Risk

K050161 is an FDA 510(k) clearance for the SYSTEM 7500-B ELECTROSURGICAL UNIT. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Conmed Electrosurgery (Centennial, US). The FDA issued a Cleared decision on February 3, 2005 after a review of 9 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 Conmed Electrosurgery devices

FDA 510(k) Submission Details - K050161

510(k) Number K050161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 2005
Decision Date February 03, 2005
Days to Decision 9 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
106d faster than avg
Panel avg: 115d · This submission: 9d
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 1617
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K050161.
MEGA POWER ELECTROSURGICAL GENERATOR
K050579 · Megadyne Medical Products, Inc. · Mar 2005
MODIFICATION TO CONCERTO BIPOLAR NEEDLE ELECTRODE
K050361 · Boston Scientific Corp · Mar 2005
MALIS 2000 BIPOLAR ELECTROSURGICAL SYSTEM
K050364 · Valley Forge Scientific Corp. · Mar 2005
E-Z PEN, REUSEABLE HANDSWITCHING PENCIL
K050102 · Megadyne Medical Products, Inc. · Feb 2005
THERMAGE THERMACOOL SYSTEM
K043402 · Thermage, Inc. · Jan 2005
SERFAS ENERGY SYSTEM
K041810 · Stryker Endoscopy · Dec 2004