Cleared Traditional

K973554 - VALLEY FORGE BIPOLAR BALL TIP ELECTRODE (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K973554 · Valley Forge Scientific Corp. · General & Plastic Surgery device
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Dec 1997
Decision
91d
Days
Class 2
Risk

K973554 is an FDA 510(k) clearance for the VALLEY FORGE BIPOLAR BALL TIP ELECTRODE. Classified as Electrode, Electrosurgical (product code JOS), Class II - Special Controls.

Submitted by Valley Forge Scientific Corp. (Oaks, US). The FDA issued a Cleared decision on December 19, 1997 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 Valley Forge Scientific Corp. devices

Submission Details

510(k) Number K973554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1997
Decision Date December 19, 1997
Days to Decision 91 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 114d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.