Cleared Traditional

K760601 - ARGYLE SUCTION CONTROL KIT

K760601 is the FDA 510(k) clearance for ARGYLE SUCTION CONTROL KIT by Sherwood Medical Co.. It is a Class 1 General & Plastic Surgery device (product code GCY) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K760601 · Sherwood Medical Co. · General & Plastic Surgery device
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Nov 1976
Decision
55d
Days
Class 1
Risk

K760601 is an FDA 510(k) clearance for the ARGYLE SUCTION CONTROL KIT. Classified as Apparatus, Suction, Single Patient Use, Portable, Nonpowered (product code GCY), Class I - General Controls.

Submitted by Sherwood Medical Co. (Mchenry, US). The FDA issued a Cleared decision on November 1, 1976 after a review of 55 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4680 - 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 Sherwood Medical Co. devices

Submission Details

510(k) Number K760601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 07, 1976
Decision Date November 01, 1976
Days to Decision 55 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
60d faster than avg
Panel avg: 115d · This submission: 55d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4680
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 - GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered

All 38
Devices cleared under the same product code (GCY) and FDA review panel - the closest regulatory comparables to K760601.
ROUND SILICONE DRAIN
K782028 · Davol, Inc. · Dec 1978
FLAT SILICONE DRAIN
K782026 · Davol, Inc. · Dec 1978
PORTABLE CLOSED WOUND SUCTION EVACUATOR
K780848 · Biomet, Inc. · Aug 1978
YASARGIL SUCTION TUBE - SMALL
K760745 · Codman & Shurtleff, Inc. · Nov 1976
YASARGIL SUCTION TUBE - LARGE
K760746 · Codman & Shurtleff, Inc. · Nov 1976
YASARGIL SUCTION TUBE - MEDIUM
K760747 · Codman & Shurtleff, Inc. · Nov 1976