Cleared Traditional

K926477 - BIFURCATED SUCTION/IRRIGAT TUBING SET W...

K926477 is an FDA 510(k) clearance for BIFURCATED SUCTION/IRRIGAT TUBING SET W..., manufactured by Core Dynamics, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GBW cleared through the Traditional 510(k) pathway after a 318-day FDA review.

K926477 · Core Dynamics, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1993
Decision
318d
Days
Class 1
Risk

K926477 is an FDA 510(k) clearance for the BIFURCATED SUCTION/IRRIGAT TUBING SET W/PUSH BUTTO. Classified as Catheter, Peritoneal (product code GBW), Class I - General Controls.

Submitted by Core Dynamics, Inc. (Jacksonville, US). The FDA issued a Cleared decision on November 12, 1993 after a review of 318 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Core Dynamics, Inc. devices

FDA 510(k) Submission Details - K926477

510(k) Number K926477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1992
Decision Date November 12, 1993
Days to Decision 318 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
203d slower than avg
Panel avg: 115d · This submission: 318d
Pathway characteristics
Predicate-based equivalence.

GBW Device Classification - Class 1, General Controls

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

All 9
Devices cleared under the same product code (GBW) and FDA review panel - the closest regulatory comparables to K926477.
MEDICOMP FLEXI-SMOOTH WOUND DRAINAGE CATHETER
K960426 · Medical Components, Inc. · Mar 1996
MEDIASTINAL SILICONE DRAINS
K942709 · Sil-Med Corp. · Jan 1996
ARGYLE TURKEL SAFETY TROCAR THORACIC CATHETER
K933510 · Sherwood Medical Co. · Feb 1994
NELSON-JUNG PLEURAL CATH
K854812 · Research Medical, Inc. · Feb 1986
DERBYSHIRE DRAIN
K843575 · Sil-Med Corp. · Oct 1984
FLAT DRAIN
K813063 · Sil-Med Corp. · Dec 1981