Cleared Traditional

K921934 - INTRADUCER

K921934 is an FDA 510(k) clearance for INTRADUCER, manufactured by Taut, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GBX cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K921934 · Taut, Inc. · General & Plastic Surgery device
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Jul 1992
Decision
82d
Days
Class 1
Risk

K921934 is an FDA 510(k) clearance for the INTRADUCER. Classified as Catheter, Irrigation (product code GBX), Class I - General Controls.

Submitted by Taut, Inc. (Geneva, US). The FDA issued a Cleared decision on July 15, 1992 after a review of 82 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4200 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Taut, Inc. devices

FDA 510(k) Submission Details - K921934

510(k) Number K921934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 1992
Decision Date July 15, 1992
Days to Decision 82 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
33d faster than avg
Panel avg: 115d · This submission: 82d
Pathway characteristics
Predicate-based equivalence.

GBX Device Classification - Class 1, General Controls

Product Code GBX Catheter, Irrigation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4200
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 - GBX Catheter, Irrigation

All 48
Devices cleared under the same product code (GBX) and FDA review panel - the closest regulatory comparables to K921934.
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K910245 · Surgical Technologies, Inc. · Apr 1991
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K905614 · Baxter Healthcare Corp · Mar 1991
PVC ROUND WOUND DRAINS
K905422 · Axiom Medical, Inc. · Feb 1991