Cleared Special

K080610 - ARTHROCARE ORTHOWAND SURGICAL DEVICE

K080610 is an FDA 510(k) clearance for ARTHROCARE ORTHOWAND SURGICAL DEVICE, manufactured by Arthrocare Corp.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Special 510(k) pathway after a 27-day FDA review.

K080610 · Arthrocare Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2008
Decision
27d
Days
Class 2
Risk

K080610 is an FDA 510(k) clearance for the ARTHROCARE ORTHOWAND SURGICAL DEVICE. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Arthrocare Corp. (Sunnyvale, US). The FDA issued a Cleared decision on March 31, 2008 after a review of 27 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.

FDA 510(k) Submission Details - K080610

510(k) Number K080610 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2008
Decision Date March 31, 2008
Days to Decision 27 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 115d · This submission: 27d
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 2310
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K080610.
BOVIE IDS-400 ELECTROSURGICAL GENERATOR
K072041 · Bovie Medical · Apr 2008
BARRX MODELS HALO360 AND HALO360+ COAGULATION CATHETERS
K080557 · Barrx Medical, Incorporated · Apr 2008
ERBE VIO ESU, MODEL VIO 200 S
K080715 · Erbe USA, Inc. · Apr 2008
PORTRAIT PSR, MODEL 745915
K073111 · Rhytec Incorporated · Mar 2008
HABIB HEXABLATE 10
K080717 · Emcision , Ltd. · Mar 2008
E-VAC
K073455 · New Leaf Medical, Inc. · Mar 2008
K080610 · ARTHROCARE ORTHOWAND SURGICAL DEVICE
Download PDF FDA Summary Arthrocare Corp.