Cleared Special

K992406 - VAPR 2.3MM END EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM

K992406 is an FDA 510(k) clearance for VAPR 2.3MM END EFFECT ELECTRODE FOR USE..., manufactured by Mitek Products. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Special 510(k) pathway after a 17-day FDA review.

K992406 · Mitek Products · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1999
Decision
17d
Days
Class 2
Risk

K992406 is an FDA 510(k) clearance for the VAPR 2.3MM END EFFECT ELECTRODE FOR USE WITH VAPR SYSTEM. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Mitek Products (Westwood, US). The FDA issued a Cleared decision on August 6, 1999 after a review of 17 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 Mitek Products devices

FDA 510(k) Submission Details - K992406

510(k) Number K992406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1999
Decision Date August 06, 1999
Days to Decision 17 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
98d faster than avg
Panel avg: 115d · This submission: 17d
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 1838
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K992406.
GEIGER ELECTROSURGICAL HANDPIECE SHEATH, MODEL 405
K992149 · Geiger Medical Technologies, Inc. · Aug 1999
SERFAS, SERFAS GENERATOR, SERFAS CONSOLE, SERFAS PROBE, SERFAS HANDPIECE CABLE, SERFAS FOOTSWITCH
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K992186 · Conmedcorp · Jul 1999
DISPOSABLE IRRIGATION BIPOLAR CORD ASSEMBLY FOR MALIS SYSTEM CMC-II, MODEL 10-4601
K992218 · Kirwan Surgical Products, Inc. · Jul 1999
ELECTROSURGICAL PROBES FAMILY: LIGAMENT CHISELS, MICRO LIGAMENT CHISELS, ABLATOR PROBES
K992408 · Oratec Interventions, Inc. · Jul 1999