Cleared Special

K062257 - STARION INSTRUMENTS THERMAL LITIGATING SHEARS

K062257 is an FDA 510(k) clearance for STARION INSTRUMENTS THERMAL LITIGATING ..., manufactured by Starion Instruments. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Special 510(k) pathway after a 67-day FDA review.

K062257 · Starion Instruments · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
67d
Days
Class 2
Risk

K062257 is an FDA 510(k) clearance for the STARION INSTRUMENTS THERMAL LITIGATING SHEARS. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Starion Instruments (Saratoga, US). The FDA issued a Cleared decision on October 10, 2006 after a review of 67 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 Starion Instruments devices

FDA 510(k) Submission Details - K062257

510(k) Number K062257 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 2006
Decision Date October 10, 2006
Days to Decision 67 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
48d faster than avg
Panel avg: 115d · This submission: 67d
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 1529
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K062257.
SKINTACT COOL CONTACT ELECTROSURGICAL GROUNDING PLATE WITH NH 04 GEL
K063161 · Leonhard Lang GmbH · Nov 2006
THERMASSAGE
K061001 · Thermage, Inc. · Oct 2006
STRYKER RF PARALLEL BIPOLAR ADAPTOR CABLE
K061660 · Stryker Instruments · Oct 2006
ADAPTABLE MONOPOLAR ADAPTABLE AND/OR RETRACTABLE ELECTRODES
K062047 · PAJUNK GmbH Medizintechnologie · Oct 2006
MODULAR LAPAROSCOPY ACCESSORIES, HANDLE
K062337 · Aaron Medical Industries · Oct 2006
PAJUNKS DISPOSABLE INSERTS FOR HANDLE INSTRUMENTS AND HF ELECTRODES
K062072 · PAJUNK GmbH Medizintechnologie · Sep 2006