Cleared Traditional

K863414 - MICROBIPOLATOR

K863414 is the FDA 510(k) clearance for MICROBIPOLATOR by Treace Medical, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K863414 · Treace Medical, Inc. · General & Plastic Surgery device
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Sep 1986
Decision
14d
Days
Class 2
Risk

K863414 is an FDA 510(k) clearance for the MICROBIPOLATOR. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Treace Medical, Inc. (Memphis, US). The FDA issued a Cleared decision on September 17, 1986 after a review of 14 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 Treace Medical, Inc. devices

Submission Details

510(k) Number K863414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 1986
Decision Date September 17, 1986
Days to Decision 14 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
101d faster than avg
Panel avg: 115d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 1188
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K863414.
MODEL FORCE 100 BIPOLAR ELECTROSURGICAL GENERATOR
K864851 · Valleylab, Inc. · Jan 1987
BIPOL CABLE
K863412 · Treace Medical, Inc. · Oct 1986
BIPOLFORCEPS
K863413 · Treace Medical, Inc. · Oct 1986
E-Z CLEAN
K862221 · American Medical Products, Inc. · Sep 1986
NEOMED NON GEL-R TOTAL ADHESIVE CONDUCT. ELECTRODE
K863360 · Richards Medical Co., Inc. · Sep 1986
ELECTRO-SURGICAL PENCILS
K861742 · Stryker Corp. · Jul 1986