Cleared Traditional

K935225 - MITEK MODULAR DRILL BIT (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K935225 · Mitek Surgical Products, Inc. · General & Plastic Surgery device
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Apr 1994
Decision
157d
Days
Class 1
Risk

K935225 is an FDA 510(k) clearance for the MITEK MODULAR DRILL BIT. Classified as Bit, Surgical (product code GFG), Class I - General Controls.

Submitted by Mitek Surgical Products, Inc. (Norwood, US). The FDA issued a Cleared decision on April 7, 1994 after a review of 157 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4820 - 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 Mitek Surgical Products, Inc. devices

Submission Details

510(k) Number K935225 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1993
Decision Date April 07, 1994
Days to Decision 157 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 114d · This submission: 157d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GFG Bit, Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4820
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.