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K Number
K990146
Device Name
SURGITRON
Manufacturer
ELLMAN INTL., INC.
Date Cleared
1999-03-17

(57 days)

Product Code
GEI
Regulation Number
878.4400
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

is idendical to the Surgitron as a preammendment device such as:

    • Cutting
      Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, Skin Incisions, Biopsy, Cysts, Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps, SkinTags, Blepharoplasty,
    • Blended Cutting and Coagulation
      Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage, Skin Tags, Papilloma Keloids, Keratosis, Verrucae, Basal CellCarcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of Skin Flaps,
    • Hemostasis Control of Bleeding, Epilation, Telangiectasia
    • Fulguration Basal Cell Carcinoma, Papilloma, Cyst Destruction, Tumors, Verrucae, Hemostasis.
    • Bipolar

Pinpoint, Precise Coagulation, Pinpoint Hemostasis in any field (Wet or Dry), Snoring, Submucosal palatal shrinkage, traditional uvulopalatoplasty (RAUP), myringotomy with effective hemorrhage control, epistaxis treatment, and turbinate shrinkage

Device Description

Not Found

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. The document is a 510(k) clearance letter from the FDA for the Surgitron IEC device, indicating that it has been deemed substantially equivalent to a pre-amendment predicate device for the listed indications for use.

This means the FDA did not require a new clinical study to demonstrate performance against specific quantitative criteria. Instead, the clearance is based on the device being similar enough to an existing, legally marketed device that it does not raise new questions of safety and effectiveness.

Therefore, I cannot populate the requested table and information, as the provided text does not contain the necessary details regarding acceptance criteria, device performance, study design, sample sizes, expert qualifications, or ground truth establishment.

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.