Cleared Traditional

K955636 - SENTRY DISPOSABLE DISPERSIVE ELECTRODE

K955636 is an FDA 510(k) clearance for SENTRY DISPOSABLE DISPERSIVE ELECTRODE, manufactured by Sentry Medical Products, Inc.. The device is a Class 2 General & Plastic Surgery device with product code JOS cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K955636 · Sentry Medical Products, Inc. · General & Plastic Surgery device
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Mar 1996
Decision
107d
Days
Class 2
Risk

K955636 is an FDA 510(k) clearance for the SENTRY DISPOSABLE DISPERSIVE ELECTRODE. Classified as Electrode, Electrosurgical (product code JOS), Class II - Special Controls.

Submitted by Sentry Medical Products, Inc. (Lombard, US). The FDA issued a Cleared decision on March 27, 1996 after a review of 107 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 Sentry Medical Products, Inc. devices

FDA 510(k) Submission Details - K955636

510(k) Number K955636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1995
Decision Date March 27, 1996
Days to Decision 107 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 115d · This submission: 107d
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 26
Devices cleared under the same product code (JOS) and FDA review panel - the closest regulatory comparables to K955636.
STANDARD & EXTENDED BLADE/NEEDLE/BALL
K971187 · Aaron Medical Industries · May 1997
MICRO DIAMOND-POINT DISSECTION NEEDLES
K962544 · Dsp Worldwide · Sep 1996
MODIFIED LEVEEN NEEDLE ELECTRODE
K962313 · Radiotherapeutics Corp. · Sep 1996
DEVICE, ELECTROSURGICAL, CUTTING AND COAGULATION & ACCESSORIES
K950455 · Aaron Medical Industries · May 1995
ELECTRODES
K944992 · Linvatec Corp. · Apr 1995
MILES SODIUM METHOD
K923037 · Heraeus Kulzer, Inc. · Sep 1992