Cleared Traditional

BAUER TEMNO COAXIAL NEEDLE (K935538) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K935538 · Bauer Medical, Inc. · General & Plastic Surgery device
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Feb 1994
Decision
98d
Days
Class 1
Risk

K935538 is an FDA 510(k) clearance for the BAUER TEMNO COAXIAL NEEDLE. Classified as Guide, Needle, Surgical (product code GDF), Class I - General Controls.

Submitted by Bauer Medical, Inc. (Palm Florida, US). The FDA issued a Cleared decision on February 22, 1994 after a review of 98 days - within the typical 510(k) review window.

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 Bauer Medical, Inc. devices

Submission Details

510(k) Number K935538 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1993
Decision Date February 22, 1994
Days to Decision 98 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
17d faster than avg
Panel avg: 115d · This submission: 98d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GDF Guide, Needle, Surgical
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.