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FDA 510(k)

Safety Lancet (XXXV)

K-Number: K241627 · 2024-06-20

ApplicantTianjin Huahong Technology Co., Ltd.
Decision Date2024-06-20
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Safety Lancet (XXXV) is a medical device manufactured by Tianjin Huahong Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-06-20 under approval number K241627. 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 Lancet (XXXV)?

Safety Lancet (XXXV) is a medical device that received FDA 510(k) clearance on 2024-06-20. It is manufactured by Tianjin Huahong Technology Co., Ltd.. The 510(k) number is K241627.

When was Safety Lancet (XXXV) approved by the FDA?

Safety Lancet (XXXV) received FDA 510(k) clearance on 2024-06-20, under approval number K241627.

What company makes Safety Lancet (XXXV)?

Safety Lancet (XXXV) is manufactured by Tianjin Huahong Technology Co., Ltd..

What is the FDA product code for Safety Lancet (XXXV)?

The FDA product code for Safety Lancet (XXXV) is FMK.

Other Devices by Tianjin Huahong Technology Co., Ltd.

K202319Insulin Pen Needle (Ordinary Type), Insulin Pen Needle (Safety Type) K220475Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T) K221176Insulin Pen Needle K220370Safety Lancet (XIII, XVII, XXI, XXII, XXIII, XXIV, XXV, XXVI) K220372Heel Stick Safety Lancet (HHZ-II, HHZ-III) K243306Lancet (IA, IB, IC, ID, IE, IK, IL, IM, IIA, IIB, III, V, VI, VII, VIII, IX); Lancing device (HH-X-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T, HH-XXV-T, HH-XXVI-T, HH-XXVIII-T, HH-XXIX-T, HH-XXX-T, HH-XIII-T, HH-XXVII-T)

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Related Devices (Code: 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.

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