SNaP Wound Care System

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

510(k) Number

K151710 ↗

FDA Product Code

OKO

Device Class

Class II

Regulation

21 CFR Part 878.4683

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Ci-Snap Wound Care System

  Class II

  FDA 510(k) K111006 Active Cleared 21 Jul 2011

• Snap Wound Care System

  Class II

  FDA 510(k) K132080 Active Cleared 12 Mar 2014

• Cisnap Closed Incision System

  Class II

  FDA 510(k) K133137 Active Cleared 25 Feb 2014

• Snap Wound Care Device

  Class II

  FDA De Novo DEN080011 Active Cleared 7 Aug 2009 FDA 510(k)

• Snap Wound Care System

  Class II

  FDA 510(k) K113032 Active Cleared 1 Dec 2011

• Snap Wound Care System

  Class II

  FDA 510(k) K112341 Active Cleared 29 Aug 2011

See all devices from Spiracur, Inc. →

• What types of wounds is the SNaP Wound Care System designed to manage, and how does it work?

  The SNaP Wound Care System is specifically designed for managing chronic, acute, traumatic, subacute, and dehisced wounds, partial-thickness burns, ulcers (including diabetic, venous, or pressure), and surgically closed incisions, flaps, and grafts. It applies controlled suction to facilitate wound healing by promoting drainage of small amounts of exudate and reducing fluid accumulation, which helps create a moist environment conducive to healing.

• Is the SNaP Wound Care System reusable or single-use, and what does that mean for clinical workflow?

  The SNaP Wound Care System is a single-use device, meaning each unit is intended for one-time use only. This design eliminates the need for sterilization between patients, simplifying workflow in both in-clinic and home-care settings while reducing the risk of cross-contamination. Clinicians should follow manufacturer instructions for proper handling and disposal after use.

• How is the SNaP Wound Care System supplied, and what should clinicians consider when storing it?

  The SNaP Wound Care System is supplied as a non-sterile, portable, non-powered device intended for use under medical supervision. Storage should follow standard medical device protocols—keep it in a clean, dry environment away from direct sunlight or extreme temperatures. Since it’s single-use, ensure proper disposal after use to comply with healthcare waste regulations.

• What regulatory pathway does the SNaP Wound Care System follow, and which medical specialties is it associated with?

  The SNaP Wound Care System was cleared via the FDA 510(k) process (K151710) under the classification of a Negative Pressure Wound Therapy Non-Powered Suction Apparatus, regulated under 21 CFR 878.4683. It is associated with the General Plastic Surgery specialty and was reviewed by the Surgical Devices (SU) Advisory Committee. The clearance confirms it is substantially equivalent to a predicate device.