Cleared Traditional

K843617 - SDC SILICONE SUMP DRAIN

K843617 is an FDA 510(k) clearance for SDC SILICONE SUMP DRAIN, manufactured by Science Development Corp.. The device is a Class 1 General & Plastic Surgery device with product code GBX cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K843617 · Science Development Corp. · General & Plastic Surgery device
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Oct 1984
Decision
40d
Days
Class 1
Risk

K843617 is an FDA 510(k) clearance for the SDC SILICONE SUMP DRAIN. Classified as Catheter, Irrigation (product code GBX), Class I - General Controls.

Submitted by Science Development Corp. (Allendale, US). The FDA issued a Cleared decision on October 24, 1984 after a review of 40 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 Science Development Corp. devices

FDA 510(k) Submission Details - K843617

510(k) Number K843617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1984
Decision Date October 24, 1984
Days to Decision 40 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
75d faster than avg
Panel avg: 115d · This submission: 40d
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 50
Devices cleared under the same product code (GBX) and FDA review panel - the closest regulatory comparables to K843617.
CLOSED PARACENTESIS SYSTEM W/BOASBERG CATHETER SET
K870704 · American Pharmaseal Div. Ahsc · Mar 1987
MICROTEK IRRIGATION SYSTEM
K844061 · Microtek Medical, Inc. · May 1985
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
IRRIGATION CATHETER
K780788 · Shiley, Inc. · Jun 1978