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FDA 510(k)

SugarBug (1.x)

K-Number: K250264 · 2025-11-07

ApplicantBench7, Inc.
Decision Date2025-11-07
Product CodeMYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SugarBug (1.x) is a medical device manufactured by Bench7, Inc.. It received FDA 510(k) clearance on 2025-11-07 under approval number K250264. The device is classified under product code MYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SugarBug (1.x)?

SugarBug (1.x) is a medical device that received FDA 510(k) clearance on 2025-11-07. It is manufactured by Bench7, Inc.. The 510(k) number is K250264.

When was SugarBug (1.x) approved by the FDA?

SugarBug (1.x) received FDA 510(k) clearance on 2025-11-07, under approval number K250264.

What company makes SugarBug (1.x)?

SugarBug (1.x) is manufactured by Bench7, Inc..

What is the FDA product code for SugarBug (1.x)?

The FDA product code for SugarBug (1.x) is MYN.

Related Devices (Code: MYN)

Official Source

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