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K Number
K983792
Device Name
SEARE BIOMEDICAL SILICONE TISSUE EXPANDER
Manufacturer
SEARE BIOMEDICAL CORP.
Date Cleared
1998-12-11

(45 days)

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

Seare Biomedical Silicone Tissue Expanders are intended for temporary subcutaneous implantation to develop surgical flaps and additional tissue coverage required in a wide variety of applications, particularly to aid in reconstruction following mastectomy, to aid in the treatment of underdeveloped breasts, and to aid in the treatment of soft tissue deformities.

Device Description

Seare Biomedical Silicone Tissue Expanders are intended for temporary subcutaneous implantation to develop surgical flaps and additional tissue coverage. The tissue expander assemblies are designed to be implanted completely under the skin, and filled externally via a syringe. All tissue expandic, incremental inflation with sterile saline for injection, until the desired amount of tissue is developed. The Seare Biomedical Silicone Tissue Expanders are constructed as a unit from silicone elastomer and consist of an expansion envelope with a smooth surface, a silicone connection tube, and a remote injection site. The expanders are available in a wide range of styles and sizes to meet diverse surgical needs.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called "Seare Biomedical Silicone Tissue Expanders." This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

Crucially, a 510(k) summary like this one generally does not include information about acceptance criteria or specific studies proving device performance beyond demonstrating substantial equivalence.

The document explicitly states:

  • "Clinical Tests: None"
  • "Adverse S&E Information: None" (referring to safety and effectiveness, implying no specific studies were conducted for this submission regarding these aspects for the new device as separate from its predicate.)

Therefore, I cannot provide the requested information because it is not present in the provided text. The submission relies on demonstrating similarity to existing devices already on the market, rather than new performance studies with acceptance criteria.

N/A