Cleared Traditional

K922289 - SESQUIPOLAR(TM) MIS ELECTRODE

K922289 is an FDA 510(k) clearance for SESQUIPOLAR(TM) MIS 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 245-day FDA review.

K922289 · Beacon Laboratories, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1993
Decision
245d
Days
Class 2
Risk

K922289 is an FDA 510(k) clearance for the SESQUIPOLAR(TM) MIS 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 January 15, 1993 after a review of 245 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 Beacon Laboratories, Inc. devices

FDA 510(k) Submission Details - K922289

510(k) Number K922289 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1992
Decision Date January 15, 1993
Days to Decision 245 days
Submission Type Traditional
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
130d slower than avg
Panel avg: 115d · This submission: 245d
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 K922289.
FOOT CONTROL PENCIL
K926306 · Megadyne Medical Products, Inc. · Feb 1993
FORCE GSU HANDSET W/LAPAROSCOPIC ELECTRODE (28CM)
K924918 · Valleylab, Inc. · Jan 1993
BIPOLAR COAGULATOR/IRRIAGATION SYSTEM
K923928 · Valley Forge Scientific Corp. · Jan 1993
DISPOSABLE HAND-SWITCHING ESU PENCIL
K925619 · Beacon Laboratories, Inc. · Dec 1992
BI-TECH I BIPOLAR COAGULATOR/CUTTING SYSTEM
K924188 · Valley Forge Scientific Corp. · Dec 1992
SYMBIOSIS SUCTION-IRRIGATOR
K923563 · Symbiosis Corp. · Nov 1992