Andiodynamics, Inc. Elvs Procedure Kit
FDA 510(k) K031233 · AngioDynamics, Inc.
510(k) numberK031233
Submission
- Device name
- Andiodynamics, Inc. Elvs Procedure Kit
- Applicant
- AngioDynamics, Inc.
Queensburgy, NY, US - Received
- April 17, 2003
- Decision date
- June 18, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GEX – Powered Laser Surgical Instrument
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4810
- Specialty
- General, Plastic Surgery
A laser (light amplification by stimulated emission of radiation) based device having coherence, collimated and typically monochromatic radiation. Typically indicated to to cut, destroy, remove or coagulate tissue, generally soft tissue, for general surgical purpose in medical specialties of general and plastic surgery, dermatology/aesthetic, podiatry, otolaryngology (ent), gynecology…
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Questions and answers
When was Andiodynamics, Inc. Elvs Procedure Kit cleared by the FDA?
Andiodynamics, Inc. Elvs Procedure Kit (K031233) received a 510(k) decision of Substantially Equivalent on June 18, 2003, 62 days after the submission was received.
What is the product code of K031233?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.