Cleared Traditional

K874719 - STRATUM ESU

K874719 is an FDA 510(k) clearance for STRATUM ESU, manufactured by Alternative Design Systems, Inc.. The device is a Class 2 General & Plastic Surgery device with product code JOS cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K874719 · Alternative Design Systems, Inc. · General & Plastic Surgery device
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Feb 1988
Decision
91d
Days
Class 2
Risk

K874719 is an FDA 510(k) clearance for the STRATUM ESU. Classified as Electrode, Electrosurgical (product code JOS), Class II - Special Controls.

Submitted by Alternative Design Systems, Inc. (Carlstadt, US). The FDA issued a Cleared decision on February 16, 1988 after a review of 91 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 Alternative Design Systems, Inc. devices

FDA 510(k) Submission Details - K874719

510(k) Number K874719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 1987
Decision Date February 16, 1988
Days to Decision 91 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
24d faster than avg
Panel avg: 115d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOS Device Classification - Class 2, Special Controls

Product Code JOS Electrode, Electrosurgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
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 - JOS Electrode, Electrosurgical

All 27
Devices cleared under the same product code (JOS) and FDA review panel - the closest regulatory comparables to K874719.
HOOK TIP SURGICAL CAUTERY ELECTRODE BLADE
K890972 · Instrument Makar, Inc. · Mar 1989
STRAIGHT PADDLE SURGICAL CAUTERY ELECTRODE BLADE
K890973 · Instrument Makar, Inc. · Mar 1989
YESNG PATIENT PLATE #80226
K881144 · Ferguson Medical · Apr 1988
MONOPOLAR CAUTERY BLADE TIP #TM-1701
K873653 · Arthropedics, Inc. · Dec 1987
MONOPOLAR CAUTERY CONICAL TIP #TM-1702
K873654 · Arthropedics, Inc. · Dec 1987
MONOPOLAR CAUTERY RETROGADE TIP #TM-1703
K873655 · Arthropedics, Inc. · Dec 1987