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FDA 510(k)

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

K-Number: K231124 · 2023-06-27

ApplicantOwen Mumford, Ltd.
Decision Date2023-06-27
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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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Related Devices (Code: FMK)

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.

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.K251694safety lancetTianjin Huahong Technology Co., Ltd.K244036Heel Incision Safety Lancet (SteriHeel 2)SteriLance Medical (Suzhou), Inc.

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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