510(k) K203293

Abbott Medical Grounding Pad, model RF-DGP-IS by ABBOTT MEDICAL — Product Code GXD

K203293 is an FDA 510(k) premarket notification submitted by ABBOTT MEDICAL for the device "Abbott Medical Grounding Pad, model RF-DGP-IS". The FDA issued a decision of Substantially Equivalent on January 21, 2022. The device falls under product code GXD (Generator, Lesion, Radiofrequency), a Class II device regulated under 21 CFR 882.4400. ABBOTT MEDICAL has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 21, 2022
Date Received
November 9, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, Lesion, Radiofrequency
Device Class
Class II
Regulation Number
882.4400
Review Panel
NE
Submission Type