Cleared Traditional

K040699 - LAPAROSCOPIC ELECTRODE, REUSABLE INDICATOR SHAFT (LERIS)

K040699 is an FDA 510(k) clearance for LAPAROSCOPIC ELECTRODE, manufactured by Megadyne Medical Products, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K040699 · Megadyne Medical Products, Inc. · General & Plastic Surgery device
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Jun 2004
Decision
79d
Days
Class 2
Risk

K040699 is an FDA 510(k) clearance for the LAPAROSCOPIC ELECTRODE, REUSABLE INDICATOR SHAFT (LERIS). Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Megadyne Medical Products, Inc. (Draper, US). The FDA issued a Cleared decision on June 4, 2004 after a review of 79 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 Megadyne Medical Products, Inc. devices

FDA 510(k) Submission Details - K040699

510(k) Number K040699 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 2004
Decision Date June 04, 2004
Days to Decision 79 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
36d faster than avg
Panel avg: 115d · This submission: 79d
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 1768
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K040699.
COBRA ADHERE SURGICAL SYSTEM
K041599 · Estech, Inc. · Jul 2004
THERMAGE THERMACOOL SYSTEM
K040135 · Thermage, Inc. · Jun 2004
STELLARTECH COAGULATION SYSTEM, MODELS 1100C-115 AND 1100C-230
K041383 · Stellartech Research Corp. · Jun 2004
MODIFICATION TO EN-BLOC BIOPSY SYSTEM
K041347 · Neothermia Corp. · Jun 2004
CONCERTO BIPOLAR NEEDLE ELECTRODE
K040785 · Boston Scientific Corp · Apr 2004
ARTHROCARE CONTROLLER, CABLE, FOOT CONTROL, POWER CORD, WANDS, MODELS H0970-02, H2000-04, H2000-05, H0970-06
K040338 · Arthrocare Corp. · Mar 2004