Cleared Traditional

K771079 - CURITY IRRIGATION TRAY

K771079 is an FDA 510(k) clearance for CURITY IRRIGATION TRAY, manufactured by Kendall Research Center. The device is a Class 1 General & Plastic Surgery device with product code GBX cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K771079 · Kendall Research Center · General & Plastic Surgery device
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Sep 1977
Decision
92d
Days
Class 1
Risk

K771079 is an FDA 510(k) clearance for the CURITY IRRIGATION TRAY. Classified as Catheter, Irrigation (product code GBX), Class I - General Controls.

Submitted by Kendall Research Center (Mchenry, US). The FDA issued a Cleared decision on September 15, 1977 after a review of 92 days - within the typical 510(k) review window.

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 Kendall Research Center devices

FDA 510(k) Submission Details - K771079

510(k) Number K771079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1977
Decision Date September 15, 1977
Days to Decision 92 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 115d · This submission: 92d
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 49
Devices cleared under the same product code (GBX) and FDA review panel - the closest regulatory comparables to K771079.
TIDAL DISTENSION IRRIGATION SET
K841362 · Abbott Laboratories · Aug 1984
ARTHROSCOPIC IRRIGATION SETS-2C4030/31
K823496 · Travenol Laboratories, S.A. · Dec 1982
IRRIGATION CATHETER
K780788 · Shiley, Inc. · Jun 1978
CATHETER, IRRIGATION
K770706 · Mallinckrodt Critical Care · May 1977
SUMP DRAIN, W/FILTER, ARGYLE EDLICH
K770442 · Sherwood Medical Industries · Mar 1977