Electrosurgical Cutting & Coagulation
FDA 510(k) K810628 · Intermedics, Inc.
510(k) numberK810628
Submission
- Device name
- Electrosurgical Cutting & Coagulation
- Applicant
- Intermedics, Inc.
Mchenry, IL, US - Received
- March 9, 1981
- Decision date
- April 3, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K954610 | Model 430-07 Endocardial Pacing LeadDTB · Traditional | 12/16/1996PT |
| K955122 | Intermedics Model 436-07 Bipolar & Model 437-07 Unipolar Implantable Endocardial Pacing…DTB · Traditional | 11/04/1996ST |
| K962174 | Biplr Im En Pac Leads (430-07,432-03,436-02 & 07, 438-05 & 07)DTB · Traditional | 08/21/1996ST |
| K955550 | Cardifix Ez Bipolar/Unipolar Endocardial Pacing LeadDTB · Traditional | 06/19/1996ST |
| K960281 | Implantable Pacing Leads/Implantable Accessory/Non-Implantable AccessoryDTB · Traditional | 06/18/1996ST |
| K954719 | Intermedics Model 430-07 Bipolar Implantable Endocardial Pacing LeadDTB · Traditional | 02/27/1996ST |
| K933278 | Intermedics Triangle Chest Probe Model 526-04KRG · Traditional | 03/15/1995SE |
| K922042 | Cardifix Endocardial Pacing LeadDTB · Traditional | 04/29/1993SESP |
| K922972 | Models 438-05 and 435-05 Implantable Pacing LeadDTB · Traditional | 01/22/1993SESP |
| K920530 | Intermedics Model 366-15 VS 1 Header PlugDXY · Traditional | 03/17/1992SE |
Questions and answers
When was Electrosurgical Cutting & Coagulation cleared by the FDA?
Electrosurgical Cutting & Coagulation (K810628) received a 510(k) decision of Substantially Equivalent on April 3, 1981, 25 days after the submission was received.
What is the product code of K810628?
The FDA product code is JOS – Electrode, Electrosurgical, a Class II (moderate risk) device regulated under 21 CFR 878.4400.