Abbott Medical Grounding Pad, model RF-DGP-IS
FDA 510(k) K203293 · Abbott Medical
510(k) numberK203293
Submission
- Device name
- Abbott Medical Grounding Pad, model RF-DGP-IS
- Applicant
- Abbott Medical
Plymouth, MN, US - Received
- November 9, 2020
- Decision date
- January 21, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Abbott Medical Grounding Pad, model RF-DGP-IS cleared by the FDA?
Abbott Medical Grounding Pad, model RF-DGP-IS (K203293) received a 510(k) decision of Substantially Equivalent on January 21, 2022, 438 days after the submission was received.
What is the product code of K203293?
The FDA product code is GXD – Generator, Lesion, Radiofrequency, a Class II (moderate risk) device regulated under 21 CFR 882.4400.