FDA 510(k)

Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G)

Número K: K231124 · 2023-06-27

Data da decisão2023-06-27

Código do produtoFMK

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G) is the device name listed in this FDA 510(k) record. The listed applicant is Owen Mumford, Ltd.. It received FDA 510(k) clearance on 2023-06-27 under 510(k) number K231124. The device is classified under product code FMK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G)?

Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G) is a medical device that received FDA 510(k) clearance on 2023-06-27. The listed applicant is Owen Mumford, Ltd.. The 510(k) number is K231124.

When did Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G) receive FDA 510(k) clearance?

Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G) received FDA 510(k) clearance on 2023-06-27, under 510(k) number K231124.

Who is the listed applicant for Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G)?

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

What is the FDA product code for Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G)?

The FDA product code for Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G) is FMK.

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Outros registros que listam Owen Mumford, Ltd. como candidato(a)

K223854Unistik® ShieldLock, Unistik VacuFlip K222168Unistik TinyTouch Steril Single-Use Heel Incisão Segurança Lancetas - Prematuro e Pós-Termo, Unistik Heelstik Steril Single-Use Heel Incisão Segurança Lancetas - MicroPrematuro, Prematuro, Pós-Termo e Criança K222303Unistik® Pro K221613Freestyle Lancing Device II, Autolet, Autolet Lite, Unilet Lancets K222111Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G K221126Unistik® 3, sterile single-use safety lancets; Unistik® 3 Value, sterile single-use safety lancets; Abbott SF sterile single-use safety lancets

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K262526Safety lancet (XL)Tianjin Huahong Technology Co., Ltd.K261045Verifine Safety LancetsPromisemed Hangzhou Meditech Co., Ltd.K260191Safety lancet (XXXVII)Tianjin Huahong Technology Co., Ltd.K253605Safety Heel LancetNingbo Medsun Medical Co., Ltd.K252490Heel Stick Safety Lancet (HHZ-II, HHZ-III, HHZ-IV)Tianjin Huahong Technology Co., Ltd.K251694Lanceta de segurançaTianjin Huahong Technology Co., Ltd.

Fonte oficial

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