Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform
FDA 510(k) K181389 · Covidien
510(k) numberK181389
Submission
- Device name
- Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform
- Applicant
- Covidien
Boulder, CO, US - Received
- May 25, 2018
- Decision date
- June 19, 2018
- 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 Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform cleared by the FDA?
Valleylab FT10 Energy Platform, Valleylab FX8 FX Series Energy Platform (K181389) received a 510(k) decision of Substantially Equivalent on June 19, 2018, 25 days after the submission was received.
What is the product code of K181389?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.