Omnitip Side Firing Switchable Tip with Suction/Irrigation, Model 20371-HP
FDA 510(k) K992230 · Trimedyne, Inc.
Submission
- Device name
- Omnitip Side Firing Switchable Tip with Suction/Irrigation, Model 20371-HP
- Applicant
- Trimedyne, Inc.
Irvine, CA, US - Received
- July 2, 1999
- Decision date
- July 12, 1999
- 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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| K041660 | Trimedyne Holmium Laser SystemsGEX · Traditional | 09/08/2004SE |
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| K013974 | Rmnipulse Holmium Laser SYSTEM/1210; MAX/1210-VHP; Jr. 1230-30; N/A 1500-AGEX · Traditional | 09/23/2002SE |
| K002308 | Omnipulse Holmium Laser System, Model 1210; Omnipulse Max Holmium Laser System, Model…GEX · Traditional | 12/20/2000SE |
| K001676 | Omnipulse Holmium Laser System, Omnipulse-Max Holmium Laser System, Model 1210…GEX · Traditional | 11/02/2000SE |
| K992574 | Omnipulse Holmium Laser System Model 1210, Omnipulse-Max Holmium Laser System Models…GEX · Traditional | 10/29/1999SE |
| K973172 | Resposable Bare FibersGEX · Traditional | 02/03/1998SE |
Questions and answers
When was Omnitip Side Firing Switchable Tip with Suction/Irrigation, Model 20371-HP cleared by the FDA?
Omnitip Side Firing Switchable Tip with Suction/Irrigation, Model 20371-HP (K992230) received a 510(k) decision of Substantially Equivalent on July 12, 1999, 10 days after the submission was received.
What is the product code of K992230?
The FDA product code is GEX – Powered Laser Surgical Instrument, a Class II (moderate risk) device regulated under 21 CFR 878.4810.