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510(k) K240069

Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M) by Endolumik — Product Code KNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 2024
Date Received
January 9, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Gastrointestinal (And Accessories)
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Other clearances by Endolumik

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  • K241185 — CORGRIP* SR NG/NI Tube Retention System (October 25, 2024)
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