Cleared Traditional

K945805 - WELLS JOHNSON WECO MONOPOLAR/FRAZIER SU...

K945805 is an FDA 510(k) clearance for WELLS JOHNSON WECO MONOPOLAR/FRAZIER SU..., manufactured by Wells Johnson Co.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K945805 · Wells Johnson Co. · General & Plastic Surgery device
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Dec 1994
Decision
15d
Days
Class 2
Risk

K945805 is an FDA 510(k) clearance for the WELLS JOHNSON WECO MONOPOLAR/FRAZIER SUCTION PROBE. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Wells Johnson Co. (Tucson, US). The FDA issued a Cleared decision on December 13, 1994 after a review of 15 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 Wells Johnson Co. devices

FDA 510(k) Submission Details - K945805

510(k) Number K945805 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1994
Decision Date December 13, 1994
Days to Decision 15 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 115d · This submission: 15d
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 1195
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K945805.
HIGH TEMPERATURE CAUTERY
K945765 · Aaron Medical Industries · Jan 1995
ELECTROSURGICAL CUTTING AND COAGULATING DEVICE AND ACCESSORIES
K943055 · Megadyne Medical Products, Inc. · Dec 1994
ELECTROSURGICAL FLEXIBLE ELECTRODE IN-LINE SUCTION COAGULATOR
K944012 · Aspen Laboratories, Inc. · Dec 1994
ELECTROSURGICAL DEVICE, CUTTING AND COAGULATION AND ACCESSORIES
K945898 · Megadyne Medical Products, Inc. · Dec 1994
MODEL E278OR-ASP SERIES RETRACTABLE
K944244 · Valleylab, Inc. · Nov 1994
SENSATEC ENDOSCOPIC INSTRUMENTS
K942080 · Linvatec Corp. · Nov 1994