Cleared Traditional

K973554 - VALLEY FORGE BIPOLAR BALL TIP ELECTRODE

K973554 is an FDA 510(k) clearance for VALLEY FORGE BIPOLAR BALL TIP ELECTRODE, manufactured by Valley Forge Scientific Corp.. 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.

K973554 · Valley Forge Scientific Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K973554

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
Combination Product No
PCCP Authorized No
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 22
Devices cleared under the same product code (JOS) and FDA review panel - the closest regulatory comparables to K973554.
ULTRABLATOR ELECTRODE
K993885 · Linvatec Corp. · Feb 2000
CAPSULAR SHRINKAGE ELECTRODE
K991830 · Linvatec Corp. · Aug 1999
STANDARD AND EXTENDED BLADE, NEEDLE AND BALL
K974735 · Aaron Medical Industries · Jun 1998
STANDARD & EXTENDED BLADE/NEEDLE/BALL
K971187 · Aaron Medical Industries · May 1997
DEVICE, ELECTROSURGICAL, CUTTING AND COAGULATION & ACCESSORIES
K950455 · Aaron Medical Industries · May 1995
ELECTRODES
K944992 · Linvatec Corp. · Apr 1995