Cleared Traditional

K915536 - DAVOL 100CC SILICONE CLOSED WOUND DRAINAGE EVAC

K915536 is an FDA 510(k) clearance for DAVOL 100CC SILICONE CLOSED WOUND DRAIN..., manufactured by Davol, Inc.. The device is a Class 1 General & Plastic Surgery device with product code GCY cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K915536 · Davol, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1992
Decision
107d
Days
Class 1
Risk

K915536 is an FDA 510(k) clearance for the DAVOL 100CC SILICONE CLOSED WOUND DRAINAGE EVAC. Classified as Apparatus, Suction, Single Patient Use, Portable, Nonpowered (product code GCY), Class I - General Controls.

Submitted by Davol, Inc. (Cranston, US). The FDA issued a Cleared decision on March 26, 1992 after a review of 107 days - within the typical 510(k) review window.

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: 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 Davol, Inc. devices

FDA 510(k) Submission Details - K915536

510(k) Number K915536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 1991
Decision Date March 26, 1992
Days to Decision 107 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 115d · This submission: 107d
Pathway characteristics
Predicate-based equivalence.

GCY Device Classification - Class 1, General Controls

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 51
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