Cleared Traditional

K895331 - ELECTROSURGICAL ELECTRODE

K895331 is an FDA 510(k) clearance for ELECTROSURGICAL ELECTRODE, manufactured by New England Surgical Instrument Corp.. The device is a Class 2 General & Plastic Surgery device with product code JOS cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K895331 · New England Surgical Instrument Corp. · General & Plastic Surgery device
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Sep 1989
Decision
16d
Days
Class 2
Risk

K895331 is an FDA 510(k) clearance for the ELECTROSURGICAL ELECTRODE. Classified as Electrode, Electrosurgical (product code JOS), Class II - Special Controls.

Submitted by New England Surgical Instrument Corp. (Rockland, US). The FDA issued a Cleared decision on September 15, 1989 after a review of 16 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all New England Surgical Instrument Corp. devices

FDA 510(k) Submission Details - K895331

510(k) Number K895331 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 1989
Decision Date September 15, 1989
Days to Decision 16 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
99d faster than avg
Panel avg: 115d · This submission: 16d
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 23
Devices cleared under the same product code (JOS) and FDA review panel - the closest regulatory comparables to K895331.
MILES SODIUM METHOD
K923037 · Heraeus Kulzer, Inc. · Sep 1992
ELECTRODE EXTENDER
K905060 · Megadyne Medical Products, Inc. · Apr 1991
ELECTRODE, ELECTROSURGERY
K903302 · Megadyne Medical Products, Inc. · Oct 1990
MICRO CAUTERY NEEDLES
K891400 · Zinnanti Surgical Instruments, Inc. · Apr 1989
HOOK TIP SURGICAL CAUTERY ELECTRODE BLADE
K890972 · Instrument Makar, Inc. · Mar 1989
STRAIGHT PADDLE SURGICAL CAUTERY ELECTRODE BLADE
K890973 · Instrument Makar, Inc. · Mar 1989