Cleared Special

K023812 - NESSY (OMEGA) DISPOSABLE SPLIT RETURN E...

K023812 is the FDA 510(k) clearance for NESSY (OMEGA) DISPOSABLE SPLIT RETURN E... by Erbe USA, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Special 510(k) pathway after a 14-day FDA review.

K023812 · Erbe USA, Inc. · General & Plastic Surgery device
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Nov 2002
Decision
14d
Days
Class 2
Risk

K023812 is an FDA 510(k) clearance for the NESSY (OMEGA) DISPOSABLE SPLIT RETURN ELECTRODES, MODELS P/N: 20193-084 AND P.... Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Erbe USA, Inc. (Marietta, US). The FDA issued a Cleared decision on November 29, 2002 after a review of 14 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 Erbe USA, Inc. devices

Submission Details

510(k) Number K023812 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 2002
Decision Date November 29, 2002
Days to Decision 14 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
101d faster than avg
Panel avg: 115d · This submission: 14d
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 1130
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K023812.
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K023886 · Erbe USA, Inc. · Dec 2002
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COBRA COOLED CARDIAC SURGICAL PROBE, MODEL 1596X
K023291 · Boston Scientific Corp · Oct 2002
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K022475 · Arthrocare Corp. · Oct 2002