BiZact Open Sealer/Divider
FDA 510(k) K160539 · Covidien
510(k) numberK160539
Submission
- Device name
- BiZact Open Sealer/Divider
- Applicant
- Covidien
Boulder, CO, US - Received
- February 26, 2016
- Decision date
- June 15, 2016
- 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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Questions and answers
When was BiZact Open Sealer/Divider cleared by the FDA?
BiZact Open Sealer/Divider (K160539) received a 510(k) decision of Substantially Equivalent on June 15, 2016, 110 days after the submission was received.
What is the product code of K160539?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.