Safety Heel Lancet
K-Number: K253605 · 2026-02-20
ApplicantNingbo Medsun Medical Co., Ltd.
Decision Date2026-02-20
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Safety Heel Lancet is a medical device manufactured by Ningbo Medsun Medical Co., Ltd.. It received FDA 510(k) clearance on 2026-02-20 under approval number K253605. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Safety Heel Lancet?
Safety Heel Lancet is a medical device that received FDA 510(k) clearance on 2026-02-20. It is manufactured by Ningbo Medsun Medical Co., Ltd.. The 510(k) number is K253605.
When was Safety Heel Lancet approved by the FDA?
Safety Heel Lancet received FDA 510(k) clearance on 2026-02-20, under approval number K253605.
What company makes Safety Heel Lancet?
Safety Heel Lancet is manufactured by Ningbo Medsun Medical Co., Ltd..
What is the FDA product code for Safety Heel Lancet?
The FDA product code for Safety Heel Lancet is FMK.
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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.