Cleared Traditional

K902996 - ARGON BEAM LAPAROSCOPIC ELECTRODE

K902996 is an FDA 510(k) clearance for ARGON BEAM LAPAROSCOPIC ELECTRODE, manufactured by Beacon Laboratories, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K902996 · Beacon Laboratories, Inc. · General & Plastic Surgery device
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Nov 1990
Decision
135d
Days
Class 2
Risk

K902996 is an FDA 510(k) clearance for the ARGON BEAM LAPAROSCOPIC ELECTRODE. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Beacon Laboratories, Inc. (Broomfield, US). The FDA issued a Cleared decision on November 21, 1990 after a review of 135 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 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 Beacon Laboratories, Inc. devices

FDA 510(k) Submission Details - K902996

510(k) Number K902996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1990
Decision Date November 21, 1990
Days to Decision 135 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d slower than avg
Panel avg: 115d · This submission: 135d
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 1424
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K902996.
VALLEYLAB LAPAROSCOPIC HANDSWITCH/ELECTRODES
K904560 · Valleylab, Inc. · Dec 1990
FORCE GSU TM SYSTEM AND FORCE GSU TM HANDSET
K904545 · Valleylab, Inc. · Dec 1990
ACTIVE ADAPTER
K904506 · Beacon Laboratories, Inc. · Dec 1990
BEAMER 1,2,4,6, AND 8
K903724 · Beacon Laboratories, Inc. · Sep 1990
ELECTROSURGICAL BIPOLAR FORCEPS
K903006 · Megadyne Medical Products, Inc. · Sep 1990
WECK ELECTROSURGICAL GENERATOR #174200
K902232 · Edward Weck, Inc. · Aug 1990