Cleared Traditional

K862221 - E-Z CLEAN

K862221 is an FDA 510(k) clearance for E-Z CLEAN, manufactured by American Medical Products, Inc.. The device is a Class 2 General & Plastic Surgery device with 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

FDA 510(k) Submission Details - K862221

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
Combination Product No
PCCP Authorized No
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.

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 1805
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