Ultrablator Electrode
FDA 510(k) K993885 · Linvatec Corp.
510(k) numberK993885
Submission
- Device name
- Ultrablator Electrode
- Applicant
- Linvatec Corp.
Largo, FL, US - Received
- November 16, 1999
- Decision date
- February 10, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JOS – Electrode, Electrosurgical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
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|---|---|---|---|
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| K050923 | Lightwave Integrated Electrode Ablator and Light Wave Integrated Electrode Suction AblatorJOS · Traditional | Conmed Linvatec | 05/18/2005SE |
| K012684 | Reprocessed Electrosurgical ElectrodeJOS · Traditional | Sterilmed, Inc. | 01/18/2002SE |
| K011515 | Medline Grounding PadJOS · Traditional | Medline Industries, Inc. | 07/13/2001SE |
| K003403 | Endoscopic Monopolareectrode, Model Eme- 1000 to 1999JOS · Traditional | Highland / Marietta, Inc. | 05/07/2001SE |
| K000333 | Standard & Extended Blade, Standard & Extended Needle, Standard & Extended Ball…JOS · Traditional | Triad Surgical Technologies, Inc. | 05/03/2000SE |
| K991830 | Capsular Shrinkage ElectrodeJOS · Traditional | Linvatec Corp. | 08/20/1999SE |
| K974735 | Standard and Extended Blade, Needle and Ball; Modified Standard and Extended Blade &…JOS · Traditional | Aaron Medical Industries | 06/24/1998SE |
| K973554 | Valley Forge Bipolar Ball Tip ElectrodeJOS · Traditional | Valley Forge Scientific Corp. | 12/19/1997SE |
| K971187 | Standard & Extended Blade/Needle/Ball;Modified Standard & Extended Blade/NeedleJOS · Traditional | Aaron Medical Industries | 05/05/1997SE |
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Questions and answers
When was Ultrablator Electrode cleared by the FDA?
Ultrablator Electrode (K993885) received a 510(k) decision of Substantially Equivalent on February 10, 2000, 86 days after the submission was received.
What is the product code of K993885?
The FDA product code is JOS – Electrode, Electrosurgical, a Class II (moderate risk) device regulated under 21 CFR 878.4400.