Skintact Cool Contact Electrosurgical Grounding Plate with NH 04 Gel
FDA 510(k) K063161 · Leonhard Lang GmbH
510(k) numberK063161
Submission
- Device name
- Skintact Cool Contact Electrosurgical Grounding Plate with NH 04 Gel
- Applicant
- Leonhard Lang GmbH
Stillwater, MN, US - Received
- October 17, 2006
- Decision date
- November 21, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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Questions and answers
When was Skintact Cool Contact Electrosurgical Grounding Plate with NH 04 Gel cleared by the FDA?
Skintact Cool Contact Electrosurgical Grounding Plate with NH 04 Gel (K063161) received a 510(k) decision of Substantially Equivalent on November 21, 2006, 35 days after the submission was received.
What is the product code of K063161?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.