Cleared Traditional

K780788 - IRRIGATION CATHETER

K780788 is an FDA 510(k) clearance for IRRIGATION CATHETER, manufactured by Shiley, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GBX cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K780788 · Shiley, Inc. · General & Plastic Surgery device
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Jun 1978
Decision
38d
Days
Class 1
Risk

K780788 is an FDA 510(k) clearance for the IRRIGATION CATHETER. Classified as Catheter, Irrigation (product code GBX), Class I - General Controls.

Submitted by Shiley, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 22, 1978 after a review of 38 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 Shiley, Inc. devices

FDA 510(k) Submission Details - K780788

510(k) Number K780788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1978
Decision Date June 22, 1978
Days to Decision 38 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 115d · This submission: 38d
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 38
Devices cleared under the same product code (GBX) and FDA review panel - the closest regulatory comparables to K780788.
VYGON CANNULA FOR SURGICAL SUCTION YAN KAUER 574/5
K851475 · Vygon Corp. · May 1985
TIDAL DISTENSION IRRIGATION SET
K841362 · Abbott Laboratories · Aug 1984
ARTHROSCOPIC IRRIGATION SETS-2C4030/31
K823496 · Travenol Laboratories, S.A. · Dec 1982
CATHETER, IRRIGATION
K770706 · Mallinckrodt Critical Care · May 1977
SUMP DRAIN, W/FILTER, ARGYLE EDLICH
K770442 · Sherwood Medical Industries · Mar 1977