Cleared Traditional

K830859 - I/A KIT

K830859 is an FDA 510(k) clearance for I/A KIT, manufactured by Surgeon Surgical Instrumentation, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GBX cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K830859 · Surgeon Surgical Instrumentation, Inc. · General & Plastic Surgery device
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May 1983
Decision
46d
Days
Class 1
Risk

K830859 is an FDA 510(k) clearance for the I/A KIT. Classified as Catheter, Irrigation (product code GBX), Class I - General Controls.

Submitted by Surgeon Surgical Instrumentation, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 2, 1983 after a review of 46 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.

FDA 510(k) Submission Details - K830859

510(k) Number K830859 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1983
Decision Date May 02, 1983
Days to Decision 46 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
69d faster than avg
Panel avg: 115d · This submission: 46d
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 76
Devices cleared under the same product code (GBX) and FDA review panel - the closest regulatory comparables to K830859.
SDC SILICONE SUMP DRAIN
K843617 · Science Development Corp. · Oct 1984
TIDAL DISTENSION IRRIGATION SET
K841362 · Abbott Laboratories · Aug 1984
SILICONE SUCTION & IRRIGATION DRAIN
K840323 · Superior Plastic Products Corp. · Apr 1984
ARTHROSCOPIC IRRIGATION SETS-2C4030/31
K823496 · Travenol Laboratories, S.A. · Dec 1982
SUCTION CATHETER W/STERILE WATER
K822510 · Medine Dynacor · Oct 1982
IRRIGATION CATHETER
K780788 · Shiley, Inc. · Jun 1978
K830859 · I/A KIT
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