Cleared Traditional

K930205 - ELECTRIC WIRE DRIVER, MODEL 2640E (FDA 510(k) Clearance)

Class I Orthopedic device.

K930205 · Micro Surgical Instruments Corp. · Orthopedic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1993
Decision
199d
Days
Class 1
Risk

K930205 is an FDA 510(k) clearance for the ELECTRIC WIRE DRIVER, MODEL 2640E. Classified as Staple Driver (product code HXJ), Class I - General Controls.

Submitted by Micro Surgical Instruments Corp. (Valencia, US). The FDA issued a Cleared decision on August 2, 1993 after a review of 199 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.4540 - 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 Micro Surgical Instruments Corp. devices

Submission Details

510(k) Number K930205 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 1993
Decision Date August 02, 1993
Days to Decision 199 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 122d · This submission: 199d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HXJ Staple Driver
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 888.4540
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.