Cleared Abbreviated

K041968 - GENICON BIPOLAR FORCEPS MODEL # 600-005-005

K041968 is an FDA 510(k) clearance for GENICON BIPOLAR FORCEPS MODEL # 600-005-005, manufactured by Genicon. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Abbreviated 510(k) pathway after a 105-day FDA review.

K041968 · Genicon · General & Plastic Surgery device
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Nov 2004
Decision
105d
Days
Class 2
Risk

K041968 is an FDA 510(k) clearance for the GENICON BIPOLAR FORCEPS MODEL # 600-005-005. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Genicon (Maitland, US). The FDA issued a Cleared decision on November 3, 2004 after a review of 105 days - within the typical 510(k) review window.

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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K041968

510(k) Number K041968 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2004
Decision Date November 03, 2004
Days to Decision 105 days
Submission Type Abbreviated
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 115d · This submission: 105d
Pathway characteristics
Standards-based clearance path.

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 2168
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K041968.
SURGRX ENSEAL VESSEL SEALING & HEMOSTASIS SYSTEM
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K041633 · Gyrus Medical, Inc. · Oct 2004
VALLY FORGE SCIENTIFIC MALIS BIPOLAR DISPOSABLE FINGER OPERATED ELECTROSURGICAL INSTRUMENTS
K042604 · Valley Forge Scientific Corp. · Oct 2004