Cleared Traditional

K872705 - BOVIE 400-CT ELECTROSURGICAL GENERATOR (UNIT)

K872705 is an FDA 510(k) clearance for BOVIE 400-CT ELECTROSURGICAL GENERATOR ..., manufactured by Clinical Technology Corp.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K872705 · Clinical Technology Corp. · General & Plastic Surgery device
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Sep 1987
Decision
56d
Days
Class 2
Risk

K872705 is an FDA 510(k) clearance for the BOVIE 400-CT ELECTROSURGICAL GENERATOR (UNIT). Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Clinical Technology Corp. (Rochester, US). The FDA issued a Cleared decision on September 1, 1987 after a review of 56 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 Clinical Technology Corp. devices

FDA 510(k) Submission Details - K872705

510(k) Number K872705 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 1987
Decision Date September 01, 1987
Days to Decision 56 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d faster than avg
Panel avg: 115d · This submission: 56d
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 1846
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K872705.
YESNG MODEL 500SII ELECTROSURGICAL UNIT
K880073 · Ferguson Medical · Mar 1988
ELECTRODE TIP CLEANER
K874775 · C.R. Bard, Inc. · Feb 1988
BIPOLATOR 50
K874779 · Treace Medical, Inc. · Jan 1988
MODEL CBC-1 COA COMP ANTI-STICKING BIPOLAR COAG.
K871077 · Radionics, Inc. · Jun 1987
MODEL 8700 BIPOLAR ELECTROSURGICAL GENERATOR
K870981 · Everest Medical Corp. · May 1987
MODEL CBC-1 COA-COMP ANTI-STICKING BIOPOLAR COAG.
K870149 · Radionics, Inc. · Apr 1987