Cleared Traditional

K943968 - TUNNELER

K943968 is an FDA 510(k) clearance for TUNNELER, manufactured by Denver Biomedicals, Inc.. The device is a Class 1 General & Plastic Surgery device with product code MDM cleared through the Traditional 510(k) pathway after a 198-day FDA review.

K943968 · Denver Biomedicals, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1995
Decision
198d
Days
Class 1
Risk

K943968 is an FDA 510(k) clearance for the TUNNELER. Classified as Instrument, Manual, Surgical, General Use (product code MDM), Class I - General Controls.

Submitted by Denver Biomedicals, Inc. (Evergreen, US). The FDA issued a Cleared decision on March 1, 1995 after a review of 198 days - an extended review 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: 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 Denver Biomedicals, Inc. devices

FDA 510(k) Submission Details - K943968

510(k) Number K943968 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1994
Decision Date March 01, 1995
Days to Decision 198 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
83d slower than avg
Panel avg: 115d · This submission: 198d
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 10
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