Cook Vascular Perfecta Electrosurgical Dissection System Ergonomic Intermittent Activation Switch
FDA 510(k) K032223 · Cook Vascular, Inc.
510(k) numberK032223
Submission
- Device name
- Cook Vascular Perfecta Electrosurgical Dissection System Ergonomic Intermittent Activation Switch
- Applicant
- Cook Vascular, Inc.
Leechburg, PA, US - Received
- July 21, 2003
- Decision date
- October 15, 2003
- 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 Cook Vascular Perfecta Electrosurgical Dissection System Ergonomic Intermittent Activation Switch cleared by the FDA?
Cook Vascular Perfecta Electrosurgical Dissection System Ergonomic Intermittent Activation Switch (K032223) received a 510(k) decision of Substantially Equivalent on October 15, 2003, 86 days after the submission was received.
What is the product code of K032223?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.