Skintact
FDA 510(k) K140500 · Leonhard Lang GmbH
510(k) numberK140500
Submission
- Device name
- Skintact
- Applicant
- Leonhard Lang GmbH
Stillwater, MN, US - Received
- February 27, 2014
- Decision date
- July 29, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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More from Stryker Sustainability Solutions
| 510(k) | Device | Decision |
|---|---|---|
| K142803 | Skintact, various other tradenamesMKJ · Traditional | 12/02/2014SE |
| K140340 | SkintactGXY · Traditional | 05/21/2014SE |
| K103186 | Skintact Radiotransparent Multifunction ElectrodesMKJ · Traditional | 02/08/2011SE |
| K092291 | Skintact and Various Other TradenamesDRX · Special | 08/21/2009SE |
| K081371 | Skintact Pediatric Multifunction Electrodes with DH03 GelMKJ · Traditional | 09/24/2008SE |
| K080106 | Skintact Pre-Wired ECG Electrodes with Conductive AdhesiveDRX · Special | 02/01/2008SE |
| K073104 | Skintact and Various Other TradenamesDRX · Special | 11/16/2007SE |
| K072233 | Skintact Multifunctional Electrodes with DH02 Gel with Different Connectors Compatible…MKJ · Special | 10/05/2007SE |
| K063161 | Skintact Cool Contact Electrosurgical Grounding Plate with NH 04 GelGEI · Special | 11/21/2006SE |
| K041883 | Skintact Multifunction Electrodes, Model DF 21MKJ · Traditional | 09/07/2004SE |
Questions and answers
When was Skintact cleared by the FDA?
Skintact (K140500) received a 510(k) decision of Substantially Equivalent on July 29, 2014, 152 days after the submission was received.
What is the product code of K140500?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.