Cleared Traditional

K935225 - MITEK MODULAR DRILL BIT

K935225 is an FDA 510(k) clearance for MITEK MODULAR DRILL BIT, manufactured by Mitek Surgical Products, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GFG cleared through the Traditional 510(k) pathway after a 157-day FDA review.

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

FDA 510(k) Submission Details - K935225

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 115d · This submission: 157d
Pathway characteristics
Predicate-based equivalence.

GFG Device Classification - Class 1, General Controls

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.