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K Number
K980930
Device Name
FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 2100 USSTA
Manufacturer
FIBRA SONICS, INC.
Date Cleared
1998-09-22

(194 days)

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

The Fibra Sonics Ultrasonic Surgical Aspirator System has been designed for use in the fragmentation, emulsification and aspiration of soft tissues as used in the following surgical areas:

  • (a) Neurosurgery
  • (b) Gastrointestinal and affiliated organ surgery
  • (c) Urological surgery
  • (d) Plastic and reconstructive surgery
  • (e) Gynecological procedures
  • (f) Orthopedic Surgery
    These indicated uses are equivalent to the predicate device. Appropriate warnings and cautions are indicated in the Operator's Manual.
Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a device called "Fibra Sonics Ultrasonic Surgical Aspirator System Model 2100 USSTA." This letter is a regulatory document and does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.

Therefore, I cannot provide the requested information from the given input. The letter primarily states that the device has been reviewed and determined to be substantially equivalent to a legally marketed predicate device, allowing it to be marketed.

N/A