Cleared Traditional

K823184 - BIPOLAR COAGULATOR #9620/9621

K823184 is an FDA 510(k) clearance for BIPOLAR COAGULATOR #9620/9621, manufactured by Concept, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K823184 · Concept, Inc. · General & Plastic Surgery device
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Dec 1982
Decision
38d
Days
Class 2
Risk

K823184 is an FDA 510(k) clearance for the BIPOLAR COAGULATOR #9620/9621. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Concept, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 3, 1982 after a review of 38 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Concept, Inc. devices

FDA 510(k) Submission Details - K823184

510(k) Number K823184 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1982
Decision Date December 03, 1982
Days to Decision 38 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
77d faster than avg
Panel avg: 115d · This submission: 38d
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 1210
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K823184.
MODEL SSE4 ELECTROSURGICAL GENERATOR
K823924 · Valleylab, Inc. · Jan 1983
BIRT-A-SWITCH DSP #712
K823491 · Birtcher Corp. · Jan 1983
ELECTROSURGICAL UNIT
K823083 · Kelleher Corp. · Dec 1982
DISP. METAL & PLASTIC ELECTROSURG. DEV
K822355 · Valleylab, Inc. · Sep 1982
CONDUCTIVE ADHESIVE DISPERSIVE ELECTRO
K822405 · Edward Weck, Inc. · Sep 1982
POLYHESIVE PATIENT RETURN ELECTRODE
K822572 · Valleylab, Inc. · Sep 1982