Cleared Traditional

K050460 - GYRUS PLASMACISION AND PLASMABLEND ELECTRODES

K050460 is an FDA 510(k) clearance for GYRUS PLASMACISION AND PLASMABLEND ELEC..., manufactured by Gyrus Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 244-day FDA review.

K050460 · Gyrus Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2005
Decision
244d
Days
Class 2
Risk

K050460 is an FDA 510(k) clearance for the GYRUS PLASMACISION AND PLASMABLEND ELECTRODES. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Gyrus Medical, Inc. (Maple Grove, US). The FDA issued a Cleared decision on October 25, 2005 after a review of 244 days - an extended review 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Gyrus Medical, Inc. devices

FDA 510(k) Submission Details - K050460

510(k) Number K050460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2005
Decision Date October 25, 2005
Days to Decision 244 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
129d slower than avg
Panel avg: 115d · This submission: 244d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 1600
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K050460.
ARTHROCARE 8000S COBLATOR SURGERY SYSTEM
K053297 · Arthrocare Corp. · Dec 2005
SOLOIST SINGLE NEEDLE ELECTRODEELECTRODE
K053128 · Boston Scientific Corp · Nov 2005
MISONIX INC. FS-1000-RF BIPOLAR FORCEPS ACCESSORY
K052702 · Misonix, Inc. · Nov 2005
ATRICURE TRANSPOLAR SYSTEM
K052893 · AtriCure, Inc. · Oct 2005
ALUMA SKIN RENEWAL SYSTEM
K051214 · Lumenis, Inc. · Oct 2005
ULTRACLEAN HANDCONTROLLED SUCTION COAGULATOR, MODEL 130182, 130183, 130184, 130185
K052104 · Conmed Corporation · Oct 2005