Cleared Traditional

K952323 - MIST ELECTROSURGICAL PROBES

K952323 is an FDA 510(k) clearance for MIST ELECTROSURGICAL PROBES, manufactured by Mist, Inc.. The device is a Class 2 General & Plastic Surgery device with product code JOS cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K952323 · Mist, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1995
Decision
36d
Days
Class 2
Risk

K952323 is an FDA 510(k) clearance for the MIST ELECTROSURGICAL PROBES, VARIOUS STYLES & SIZES. Classified as Electrode, Electrosurgical (product code JOS), Class II - Special Controls.

Submitted by Mist, Inc. (Great Neck, US). The FDA issued a Cleared decision on June 23, 1995 after a review of 36 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 Mist, Inc. devices

FDA 510(k) Submission Details - K952323

510(k) Number K952323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1995
Decision Date June 23, 1995
Days to Decision 36 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
79d faster than avg
Panel avg: 115d · This submission: 36d
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 K952323.
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