FDA.reportPublic FDA data

ENDOLUMIK

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30266719983026671998ENDOLUMIK1N2026-01-01364 Patteson Dr. #293 Morgantown WV US 26505

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
G461EGCT360Endolumik - Endolumik Gastric Calibration Tube 36F304-207-0072owens@endolumik.com
G461EGCT361Endolumik - Endolumik Gastric Calibration Tube 36F304-207-0072owens@endolumik.com
G461EGCT36M0Endolumik - 36F Endolumik Gastric Calibration Tube, M Series304-207-0072customerservice@endolumik.com
G461EGCT36M1Endolumik - 36F Endolumik Gastric Calibration Tube, M Series304-207-0072customerservice@endolumik.com
G461EGCT400Endolumik - Endolumik Gastric Calibration Tube, 40F304-207-0072owens@endolumik.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3152941811154553K240069Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M)KNT2024-02-08
3152941228626990K222880Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie)KNT2023-03-03
3152941528902439

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KNT22024-02-08

PMN#

GUDID#