Cleared Special

K031846 - CARDIOVATIONS OPTICAL BIPOLAR DEVICE

K031846 is the FDA 510(k) clearance for CARDIOVATIONS OPTICAL BIPOLAR DEVICE by Ethicon, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Special 510(k) pathway after a 35-day FDA review.

K031846 · Ethicon, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
35d
Days
Class 2
Risk

K031846 is an FDA 510(k) clearance for the CARDIOVATIONS OPTICAL BIPOLAR 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 Ethicon, Inc. (Somerville, US). The FDA issued a Cleared decision on July 21, 2003 after a review of 35 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 Ethicon, Inc. devices

Submission Details

510(k) Number K031846 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2003
Decision Date July 21, 2003
Days to Decision 35 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
80d faster than avg
Panel avg: 115d · This submission: 35d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 1118
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K031846.
ARTHROCARE ENT PLASMA WANDS
K033257 · Arthrocare Corp. · Oct 2003
ARTHROCARE SYSTEM
K032504 · Arthrocare Corp. · Aug 2003
COBRA COOLED SURGICAL PROBE, MODEL M004159670
K032207 · Boston Scientific Corp · Aug 2003
CARDIOBLATE BIPOLAR RADIOFREQUENCY SURGICAL ABLATION SYSTEM
K031247 · Medtronic Vascular · Jul 2003
SMITH & NEPHEW DYONICS ELECTROBLADE RESECTOR
K031675 · Smith & Nephew, Inc. · Jun 2003
ULTRABLATOR ELECTRODE
K030720 · Linvatec Corp. · Jun 2003