Standard and Extended Blade, Needle and Ball; Modified Standard and Extended Blade & Needle; Standard 45 Degree Blade
FDA 510(k) K974735 · Aaron Medical Industries
510(k) numberK974735
Submission
- Device name
- Standard and Extended Blade, Needle and Ball; Modified Standard and Extended Blade & Needle; Standard 45 Degree Blade
- Applicant
- Aaron Medical Industries
St. Petersburg, FL, US - Received
- December 18, 1997
- Decision date
- June 24, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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|---|---|---|---|
| K161600 | Resection ElectrodesJOS · Traditional | Olympus Winter & Ibe GmbH | 09/06/2016SE |
| 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 |
| K993885 | Ultrablator ElectrodeJOS · Traditional | Linvatec Corp. | 02/10/2000SE |
| K991830 | Capsular Shrinkage ElectrodeJOS · Traditional | Linvatec Corp. | 08/20/1999SE |
| 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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| K062337 | Modular Laparoscopy Accessories, Handle; Sissors (Straight and Curved); Grasper…GEI · Traditional | 10/05/2006SE |
| K061307 | Bovie Inaflash Suture Remover Handle,Charger,Handle and Charger,Kit,Battery PackGEI · Traditional | 07/18/2006SE |
| K060117 | Bovie Button Remote Hand SwitchGEI · Traditional | 02/22/2006SE |
| K022856 | Bovie IDS-300 High Frequency Electrosurgical GeneratorGEI · Traditional | 02/10/2003SE |
| K021817 | Aaron A950 High Frequency Electrosurgical Generator, Aaron A950 Electrosurgical…GEI · Traditional | 07/11/2002SE |
| K020579 | Aaron Arthroscopy Electrode, Catalog Numbers AR00, AR01, AR02, and AR03GEI · Traditional | 05/13/2002SE |
| K014201 | Aaron Reusable Electrosurgical ElectrodeGEI · Traditional | 02/25/2002SE |
| K001955 | Aaron 1250 High Frequency Electrosurgical Generator, Model A1250GEI · Traditional | 12/22/2000SE |
| K001382 | Aaron 2100 High Frequency Electrosurgical GeneratorGEI · Traditional | 06/27/2000SE |
| K000961 | Aaron 900 High Frequency Dessiccator/HandpieceGEI · Special | 04/19/2000SE |
Questions and answers
When was Standard and Extended Blade, Needle and Ball; Modified Standard and Extended Blade & Needle; Standard 45 Degree Blade cleared by the FDA?
Standard and Extended Blade, Needle and Ball; Modified Standard and Extended Blade & Needle; Standard 45 Degree Blade (K974735) received a 510(k) decision of Substantially Equivalent on June 24, 1998, 188 days after the submission was received.
What is the product code of K974735?
The FDA product code is JOS – Electrode, Electrosurgical, a Class II (moderate risk) device regulated under 21 CFR 878.4400.