Cleared Traditional

K864851 - MODEL FORCE 100 BIPOLAR ELECTROSURGICAL...

K864851 is an FDA 510(k) clearance for MODEL FORCE 100 BIPOLAR ELECTROSURGICAL..., manufactured by Valleylab, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K864851 · Valleylab, Inc. · General & Plastic Surgery device
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Jan 1987
Decision
29d
Days
Class 2
Risk

K864851 is an FDA 510(k) clearance for the MODEL FORCE 100 BIPOLAR ELECTROSURGICAL GENERATOR. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Valleylab, Inc. (Boulder, US). The FDA issued a Cleared decision on January 8, 1987 after a review of 29 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 Valleylab, Inc. devices

FDA 510(k) Submission Details - K864851

510(k) Number K864851 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1986
Decision Date January 08, 1987
Days to Decision 29 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
86d faster than avg
Panel avg: 115d · This submission: 29d
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 1192
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K864851.
MODEL CBC-1 COA-COMP ANTI-STICKING BIOPOLAR COAG.
K870149 · Radionics, Inc. · Apr 1987
ELECTROSURGICAL MENISCUS CUTTER (EMC) MOD. AMC-100
K870269 · American Bentley · Mar 1987
MODEL FORCE 4B ELECTROSURGICAL GENERATOR
K864675 · Valleylab, Inc. · Jan 1987
BIPOL CABLE
K863412 · Treace Medical, Inc. · Oct 1986
BIPOLFORCEPS
K863413 · Treace Medical, Inc. · Oct 1986
MICROBIPOLATOR
K863414 · Treace Medical, Inc. · Sep 1986