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Wound Care Compression System (WCCS)

by Suncoast Medical Products, Inc.

510(k) K960585

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK960585 Date26 Apr 1996ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MCY
Device Class
Class II
Regulation
21 CFR Part 880.5075
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Wound Care Compression System (WCCS) is a wound dressing kit designed to provide compression therapy for wound management. It is classified as a Class II medical device and includes components intended to apply controlled pressure to promote healing in chronic or acute wounds, such as venous leg ulcers or post-surgical incisions. The system is structured to facilitate proper compression while maintaining a sterile environment around the wound site.

The WCCS is supplied as a single-use device and is intended for use in general hospital settings. It includes multiple components, each identified by unique registration numbers, and is regulated under FDA 510(k) clearance (K960585) as substantially equivalent to a predicate device. Storage and handling instructions are not specified in the data, but compliance with standard wound care protocols is implied. The device is not described as MRI-safe or reusable, and its regulatory status is explicitly noted as an FDA 510(k) clearance.