Cleared Traditional

K972112 - INTRADUCER PORT SC CATALOG#31275

K972112 is the FDA 510(k) clearance for INTRADUCER PORT SC CATALOG#31275 by Taut, Inc.. It is a Class 1 General & Plastic Surgery device (product code GBW) cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K972112 · Taut, Inc. · General & Plastic Surgery device
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Dec 1997
Decision
179d
Days
Class 1
Risk

K972112 is an FDA 510(k) clearance for the INTRADUCER PORT SC CATALOG#31275,31035,30915, AND 31450. Classified as Catheter, Peritoneal (product code GBW), Class I - General Controls.

Submitted by Taut, Inc. (Geneva, US). The FDA issued a Cleared decision on December 1, 1997 after a review of 179 days - an extended review 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: 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 Taut, Inc. devices

Submission Details

510(k) Number K972112 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 1997
Decision Date December 01, 1997
Days to Decision 179 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
64d slower than avg
Panel avg: 115d · This submission: 179d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GBW Catheter, Peritoneal
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 - GBW Catheter, Peritoneal

Devices cleared under the same product code (GBW) and FDA review panel - the closest regulatory comparables to K972112.
MEDICOMP FLEXI-SMOOTH WOUND DRAINAGE CATHETER
K960426 · Medical Components, Inc. · Mar 1996
ARGYLE TURKEL SAFETY TROCAR THORACIC CATHETER
K933510 · Sherwood Medical Co. · Feb 1994
NELSON-JUNG PLEURAL CATH
K854812 · Research Medical, Inc. · Feb 1986
ARROW PERITONEAL LAVAGE CATHERIZATION K
K811627 · Arrow Intl., Inc. · Aug 1981
PERCUTANEOUS DRAINING CATHETER
K811378 · Medi-Tech, Inc. · Jun 1981