Reprocessed Electrosurgical Electrode
FDA 510(k) K012684 · Sterilmed, Inc.
510(k) numberK012684
Submission
- Device name
- Reprocessed Electrosurgical Electrode
- Applicant
- Sterilmed, Inc.
Maple Grove, MN, US - Received
- August 14, 2001
- Decision date
- January 18, 2002
- 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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| K993885 | Ultrablator ElectrodeJOS · Traditional | Linvatec Corp. | 02/10/2000SE |
| 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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| K161700 | SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D…OWQ · Traditional | 11/21/2016SE |
| K161086 | Reprocessed Harmonic Shears with Adaptive Tissue Technology (36 cm), Reprocessed…NUJ · Traditional | 09/20/2016SE |
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Questions and answers
When was Reprocessed Electrosurgical Electrode cleared by the FDA?
Reprocessed Electrosurgical Electrode (K012684) received a 510(k) decision of Substantially Equivalent on January 18, 2002, 157 days after the submission was received.
What is the product code of K012684?
The FDA product code is JOS – Electrode, Electrosurgical, a Class II (moderate risk) device regulated under 21 CFR 878.4400.