Cleared Traditional

K962590 - SIGNALDRESS

K962590 · Convatec, A Division of E.R. Squibb & Sons · General & Plastic Surgery device
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Sep 1996
Decision
80d
Days
-
Risk

K962590 is an FDA 510(k) clearance for the SIGNALDRESS. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Convatec, A Division of E.R. Squibb & Sons (Skillman, US). The FDA issued a Cleared decision on September 20, 1996 after a review of 80 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 Convatec, A Division of E.R. Squibb & Sons devices

FDA 510(k) Submission Details - K962590

510(k) Number K962590 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received July 02, 1996
Decision Date September 20, 1996
Days to Decision 80 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
35d faster than avg
Panel avg: 115d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

FRO Device Classification - Class 0,

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

All 501
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K962590.
HYDROCOLLOID WOUND DRESSINGS
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MITRAFLEX PIGMENTED WOUND DRESSING
K964701 · Polymedica Industries, Inc. · Feb 1997
SURESKIN STANDARD, BORDER, AND THIN
K963039 · Euromed A/S · Sep 1996
TECNOL SALINE WET DRESSING
K954243 · Tecnol Medical Products, Inc. · Nov 1995
DERMAGRAN HYDROPHILIC OINTMENT
K954739 · Derma Sciences, Inc. · Nov 1995
DERMAGRAN WOUND DRESSING
K954740 · Derma Sciences, Inc. · Nov 1995