Cleared Traditional

K050957 - EUTROCHAR

K050957 is an FDA 510(k) clearance for EUTROCHAR, manufactured by Special Devices, Inc.. The device is a Class 1 General & Plastic Surgery device with product code MDM cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K050957 · Special Devices, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
33d
Days
Class 1
Risk

K050957 is an FDA 510(k) clearance for the EUTROCHAR. Classified as Instrument, Manual, Surgical, General Use (product code MDM), Class I - General Controls.

Submitted by Special Devices, Inc. (Grass Valley, US). The FDA issued a Cleared decision on May 18, 2005 after a review of 33 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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.

FDA 510(k) Submission Details - K050957

510(k) Number K050957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2005
Decision Date May 18, 2005
Days to Decision 33 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
82d faster than avg
Panel avg: 115d · This submission: 33d
Pathway characteristics
Predicate-based equivalence.

MDM Device Classification - Class 1, General Controls

Product Code MDM Instrument, Manual, Surgical, General Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - MDM Instrument, Manual, Surgical, General Use

All 42
Devices cleared under the same product code (MDM) and FDA review panel - the closest regulatory comparables to K050957.
FRONTLINE MEDICAL SAFETYNET GUIDEWIRE INTRODUCER
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FUTUMEDS NO PATIENT CONTACT SAFETY LANCET WITH PALS SYSTEM
K050575 · Futumeds Sdn Bhd · Aug 2005
ANDREWS INTRODUCER, MODEL ASI01
K023173 · Andrews Surgical Innovations, Ltd. · Dec 2002
MICROVASIVE PULMONARY GUIDEWIRE
K022059 · Boston Scientific Corp · Nov 2002
LIGHT SABER INTRODUCER NEEDLE
K013040 · Minrad, Inc. · Dec 2001
CHESS HAND SURGERY SYSTEM
K010184 · Canica Design, Inc. · Jun 2001
K050957 · EUTROCHAR
Download PDF FDA Summary Special Devices, Inc.