Cleared Traditional

K862221 - E-Z CLEAN

K862221 is the FDA 510(k) clearance for E-Z CLEAN by American Medical Products, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K862221 · American Medical Products, Inc. · General & Plastic Surgery device
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Sep 1986
Decision
93d
Days
Class 2
Risk

K862221 is an FDA 510(k) clearance for the E-Z CLEAN. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by American Medical Products, Inc. (Sandy, US). The FDA issued a Cleared decision on September 12, 1986 after a review of 93 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all American Medical Products, Inc. devices

Submission Details

510(k) Number K862221 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1986
Decision Date September 12, 1986
Days to Decision 93 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
22d faster than avg
Panel avg: 115d · This submission: 93d
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 1141
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K862221.
BIPOL CABLE
K863412 · Treace Medical, Inc. · Oct 1986
BIPOLFORCEPS
K863413 · Treace Medical, Inc. · Oct 1986
MICROBIPOLATOR
K863414 · Treace Medical, 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
MODEL E2517 AND MODEL E2503 POWER CONTROL PENCILS
K861112 · Valleylab, Inc. · May 1986