Cleared Traditional

K113545 - VAPR VUE GENERATOR, VAPR 3 ELECTROSURGICAL SYSTEM, VAPR II ELECTROSURGICAL SYSTEM COOLPLUSE 90 AND COOLPLUSE 90 WITH HAN

K113545 is an FDA 510(k) clearance for VAPR VUE GENERATOR, manufactured by Depuy Mitek, A Johnson & Johnson Company. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K113545 · Depuy Mitek, A Johnson & Johnson Company · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2012
Decision
88d
Days
Class 2
Risk

K113545 is an FDA 510(k) clearance for the VAPR VUE GENERATOR, VAPR 3 ELECTROSURGICAL SYSTEM, VAPR II ELECTROSURGICAL SY.... Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Depuy Mitek, A Johnson & Johnson Company (Raynham, US). The FDA issued a Cleared decision on February 27, 2012 after a review of 88 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Depuy Mitek, A Johnson & Johnson Company devices

FDA 510(k) Submission Details - K113545

510(k) Number K113545 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2011
Decision Date February 27, 2012
Days to Decision 88 days
Submission Type Traditional
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
27d faster than avg
Panel avg: 115d · This submission: 88d
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 1749
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K113545.
LEVEEN SUPERSLIM NEEDLE ELECTRODE
K113090 · Boston Scientific Corporation · Mar 2012
OSTEOCOOL (TM) RF ABLATION SYSTEM
K111523 · Baylis Medical Co., Inc. · Mar 2012
VENUS FREEZE (MP)2 SYSTEM
K111670 · Venus Concept , Ltd. · Mar 2012
BOVIE J-PLASMA HANDPIECE WITH RETRACTABLE CUTTING BLADE
K112233 · Bovie Medical Corporation · Jan 2012
LOGIC LAPAROSCOPIC INSTRUMENT SYSTEM
K111986 · Surgical Innovations Plc · Jan 2012
SURGICAL TISSUE MANAGEMENT SYSTEM
K111202 · Olympus Medical Systems Corp. · Jan 2012