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FDA 510(k)

Stelo Glucose Biosensor System

K-Number: K234070 · 2024-03-05

ApplicantDexcom, Inc.
Decision Date2024-03-05
Product CodeSAF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Stelo Glucose Biosensor System is the device name listed in this FDA 510(k) record. The listed applicant is Dexcom, Inc.. It received FDA 510(k) clearance on 2024-03-05 under 510(k) number K234070. The device is classified under product code SAF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stelo Glucose Biosensor System?

Stelo Glucose Biosensor System is a medical device that received FDA 510(k) clearance on 2024-03-05. The listed applicant is Dexcom, Inc.. The 510(k) number is K234070.

When did Stelo Glucose Biosensor System receive FDA 510(k) clearance?

Stelo Glucose Biosensor System received FDA 510(k) clearance on 2024-03-05, under 510(k) number K234070.

Who is the listed applicant for Stelo Glucose Biosensor System?

The FDA 510(k) record lists Dexcom, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Stelo Glucose Biosensor System?

The FDA product code for Stelo Glucose Biosensor System is SAF.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07422831T2D Intermittent Nonprescription Sensors for Informed Glucose Health TrackingENROLLING_BY_INVITATIONNCT06601166CONtiNuous glucosE Monitoring (CGM) in People wiTh Type 2 Diabetes Not on InsulinACTIVE_NOT_RECRUITINGNCT07603284Continuous Glucose Monitoring By DExcom iN PEople Followed for Type 2 DIabeTes on Insulin Therapy in the Kingdom of Saudi ArabiaACTIVE_NOT_RECRUITINGNCT07681024Global Long-term Outcomes and Real-World Evaluation of Dexcom Continuous Glucose Monitoring System (Dexcom GLOW)NOT_YET_RECRUITINGNCT07681375Evaluation of Basal Insulin Initialization and Titration in People With Type 2 Diabetes Wearing a Dexcom G6 SensorACTIVE_NOT_RECRUITING

Other records listing Dexcom, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262472Stelo Glucose Biosensor SystemK260935Stelo Glucose Biosensor SystemK261402Dexcom G7 Continuous Glucose Monitoring System;Dexcom G7 15 Day Continuous Glucose Monitoring SystemK261359Stelo Glucose Biosensor SystemK253737Dexcom G7 Continuous Glucose Monitoring (CGM) System; Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) SystemK253710Dexcom G7 Continuous Glucose Monitoring (CGM) System, Dexcom G7 15 Day Continuous Glucose Monitoring (CGM) System

View all 26 devices →

Related Devices (Code: SAF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261359Stelo Glucose Biosensor SystemDexcom, Inc.K250106Signos Glucose Monitoring SystemSignos, Inc.K233655Lingo Glucose SystemAbbott

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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