Cleared Traditional

K934176 - SURGICAL ACCESSORIES LOOPED WIRE

K934176 is an FDA 510(k) clearance for SURGICAL ACCESSORIES LOOPED WIRE, manufactured by Surgical Accessories, Inc.. The device is a Class 2 Orthopedic device with product code JDQ cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K934176 · Surgical Accessories, Inc. · Orthopedic device
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Feb 1994
Decision
179d
Days
Class 2
Risk

K934176 is an FDA 510(k) clearance for the SURGICAL ACCESSORIES LOOPED WIRE. Classified as Cerclage, Fixation (product code JDQ), Class II - Special Controls.

Submitted by Surgical Accessories, Inc. (St. Louis, US). The FDA issued a Cleared decision on February 22, 1994 after a review of 179 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3010 - the FDA orthopedic device regulatory 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 Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all Surgical Accessories, Inc. devices

FDA 510(k) Submission Details - K934176

510(k) Number K934176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1993
Decision Date February 22, 1994
Days to Decision 179 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
57d slower than avg
Panel avg: 122d · This submission: 179d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JDQ Device Classification - Class 2, Special Controls

Product Code JDQ Cerclage, Fixation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3010
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 Orthopedic devices follow this clearance model.

Regulatory Peers - JDQ Cerclage, Fixation

All 120
Devices cleared under the same product code (JDQ) and FDA review panel - the closest regulatory comparables to K934176.
CONTROL CABLE SYSTEM
K934557 · Depuy, Inc. · Feb 1994
DALL MILES SYSTEM MINICLEAT
K934058 · Howmedica Corp. · Feb 1994
CERCLAGE WIRE CRIMP SLEEVE
K931246 · Acu Med, Inc. · Feb 1994
SPONGER CABLE SYSTEM, MODIFICATION
K935481 · Pioneer Surgical Technology · Jan 1994
ORTHOPAEDIC POLYETHYLENE CABLE
K924141 · Smith & Nephew Richards, Inc. · Nov 1993
OTI ORTHOPEDIC WIRE SYSTEM
K925447 · Osteo Technology, Inc. · Jun 1993