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K Number
K022967
Device Name
SUILE WOUND DRESSING
Manufacturer
HEDONIST BIOCHEMICAL TECHNOLOGIES CO., LTD.
Date Cleared
2003-07-08

(305 days)

Product Code
FRO
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The SUILE Wound Dressing is indicated for the management of 1st and 2nd degree burns, partial thickness wounds, donor sites and abrasions.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device called the "SUILE Wound Dressing." It states that the device is substantially equivalent to a legally marketed predicate device.

The request asks for acceptance criteria and a study that proves the device meets those criteria. However, this type of information is not present in the provided FDA 510(k) clearance letter.

Here's why and what kind of information is typically found in such a letter:

  • 510(k) letters primarily communicate that a device has been found "substantially equivalent" to a predicate device already on the market. This means the FDA believes the new device is as safe and effective as the predicate and does not raise new questions of safety or effectiveness.
  • They do not typically contain detailed study results, acceptance criteria, or performance data. Those details are part of the original 510(k) submission that the manufacturer provides to the FDA, but they are generally not summarized or included in the public clearance letter itself. The letter simply confirms the FDA's decision based on its review of that submission.

Therefore, I cannot fulfill your request for the tables and study details based on the provided text. The document only contains the following relevant information:

  • Trade/Device Name: SUILE Wound Dressing
  • Regulatory Class: Unclassified
  • Product Code: FRO
  • Indications For Use: The SUILE Wound Dressing is indicated for the management of 1st and 2nd degree burns, partial thickness wounds, donor sites and abrasions.
  • Predicate Device: The letter states the device is "substantially equivalent... to legally marketed predicate devices," but it does not name the specific predicate device.

To get the information you're asking for, one would typically need to review the full 510(k) submission, which is often much more extensive than the clearance letter.

N/A