Varpr 3.5MM 90 Suction Electrode for Use with Vapr System
FDA 510(k) K002422 · Mitek Products
510(k) numberK002422
Submission
- Device name
- Varpr 3.5MM 90 Suction Electrode for Use with Vapr System
- Applicant
- Mitek Products
Norwood, MA, US - Received
- August 8, 2000
- Decision date
- August 31, 2000
- 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 Varpr 3.5MM 90 Suction Electrode for Use with Vapr System cleared by the FDA?
Varpr 3.5MM 90 Suction Electrode for Use with Vapr System (K002422) received a 510(k) decision of Substantially Equivalent on August 31, 2000, 23 days after the submission was received.
What is the product code of K002422?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.