Sentry Disposable Dispersive Electrode
FDA 510(k) K955636 · Sentry Medical Products, Inc.
510(k) numberK955636
Submission
- Device name
- Sentry Disposable Dispersive Electrode
- Applicant
- Sentry Medical Products, Inc.
Lombard, IL, US - Received
- December 11, 1995
- Decision date
- March 27, 1996
- 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 |
| 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 |
More from Valley Forge Scientific Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K962122 | Sentry Radiotranslucent ECG ElectrodesDRX · Traditional | 07/24/1996SE |
| K942827 | Sentry Insertion TrayFOS · Traditional | 11/02/1994SE |
| K934000 | Sentry Aqueous Gel ECG ElectrodesDRX · Traditional | 08/30/1994SE |
| K935098 | Baby BoardBTX · Traditional | 02/15/1994SE |
| K933603 | LeadwireDSA · Traditional | 01/18/1994SE |
| K932704 | Patient CableDSA · Traditional | 12/27/1993SE |
| K881670 | Accutemp PlusFMT · Traditional | 11/22/1988SE |
| K881343 | Duraderm ButterflyGXY · Traditional | 05/04/1988SE |
| K851522 | Diagnostic ECG Disposable ElectrodeDRX · Traditional | 10/24/1985SE |
| K853552 | Sentry Flexible TENSGXY · Traditional | 09/26/1985SE |
Questions and answers
When was Sentry Disposable Dispersive Electrode cleared by the FDA?
Sentry Disposable Dispersive Electrode (K955636) received a 510(k) decision of Substantially Equivalent on March 27, 1996, 107 days after the submission was received.
What is the product code of K955636?
The FDA product code is JOS – Electrode, Electrosurgical, a Class II (moderate risk) device regulated under 21 CFR 878.4400.