Cleared Traditional

K163442 - Single Use Micro Electrode (Brass with ...

Also marketed or referenced as:
Single Use Micro Electrode (Stainless Steel shaft)

K163442 is an FDA 510(k) clearance for Single Use Micro Electrode (Brass with ..., manufactured by Modern Medical Equipment Manufacturing Limited. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 294-day FDA review.

K163442 · Modern Medical Equipment Manufacturing Limited · General & Plastic Surgery device
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Sep 2017
Decision
294d
Days
Class 2
Risk

K163442 is an FDA 510(k) clearance for the Single Use Micro Electrode (Brass with gold plated shaft). Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Modern Medical Equipment Manufacturing Limited (Hong Kong, CN). The FDA issued a Cleared decision on September 28, 2017 after a review of 294 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Modern Medical Equipment Manufacturing Limited devices

FDA 510(k) Submission Details - K163442

510(k) Number K163442 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2016
Decision Date September 28, 2017
Days to Decision 294 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
179d slower than avg
Panel avg: 115d · This submission: 294d
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.

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