Cleared Traditional

K860236 - PHAKOSYSTEMS CT-100 CAUTERY MODULE

K860236 is an FDA 510(k) clearance for PHAKOSYSTEMS CT-100 CAUTERY MODULE, manufactured by Phakosystems, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K860236 · Phakosystems, Inc. · General & Plastic Surgery device
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Feb 1986
Decision
27d
Days
Class 2
Risk

K860236 is an FDA 510(k) clearance for the PHAKOSYSTEMS CT-100 CAUTERY MODULE. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Phakosystems, Inc. (Downsview M3j 2t9, CA). The FDA issued a Cleared decision on February 19, 1986 after a review of 27 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 Phakosystems, Inc. devices

FDA 510(k) Submission Details - K860236

510(k) Number K860236 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1986
Decision Date February 19, 1986
Days to Decision 27 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
88d faster than avg
Panel avg: 115d · This submission: 27d
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 1871
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K860236.
E7509 POLYHESIVE II PATIENT RETURN ELECTRODE
K861036 · Valleylab, Inc. · May 1986
BIRT-A-SWITCH, DSP PUSH BUTTON, MODEL NO. 768
K860687 · Birtcher Corp. · Mar 1986
ELECTROSURGERY PENCIL, MODEL 767
K860718 · Birtcher Corp. · Mar 1986
SURGICAL CAUTERIES MODELS 775-11,12,13,31,32 & 33
K854814 · Birtcher Corp. · Jan 1986
BI-POLAR FORCEPS
K854864 · Birtcher Corp. · Dec 1985
MALIS MICRO BIPOLAR COAGULATOR
K854592 · Valley Forge Scientific Corp. · Dec 1985