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Snap Wound Care System

by Spiracur, Inc.

510(k) K111393

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK111393 Date28 Jul 2011ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Snap (R) Wound Care System
510(k) Number
FDA Product Code
OKO
Device Class
Class II
Regulation
21 CFR Part 878.4683
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 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 Snap Wound Care System is a negative pressure wound therapy non-powered suction apparatus. It is designed to manage wounds by applying negative pressure to promote healing through the removal of excess exudate, infectious material, and tissue debris.

This system is authorized via FDA 510k clearance. It is intended for use in patients who would benefit from wound management via negative pressure application.

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