Trimedyne Side Firing Needle with Vent Sheath
FDA 510(k) K022655 · Trimedyne, Inc.
510(k) numberK022655
Submission
- Device name
- Trimedyne Side Firing Needle with Vent Sheath
- Applicant
- Trimedyne, Inc.
Irvine, CA, US - Received
- August 9, 2002
- Decision date
- November 7, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| K992574 | Omnipulse Holmium Laser System Model 1210, Omnipulse-Max Holmium Laser System Models…GEX · Traditional | 10/29/1999SE |
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Questions and answers
When was Trimedyne Side Firing Needle with Vent Sheath cleared by the FDA?
Trimedyne Side Firing Needle with Vent Sheath (K022655) received a 510(k) decision of Substantially Equivalent on November 7, 2002, 90 days after the submission was received.
What is the product code of K022655?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.