Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G
K-Number: K222111 · 2022-09-07
ApplicantOwen Mumford, Ltd.
Decision Date2022-09-07
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G is a medical device manufactured by Owen Mumford, Ltd.. It received FDA 510(k) clearance on 2022-09-07 under approval number K222111. 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 Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G?
Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G is a medical device that received FDA 510(k) clearance on 2022-09-07. It is manufactured by Owen Mumford, Ltd.. The 510(k) number is K222111.
When was Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G approved by the FDA?
Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G received FDA 510(k) clearance on 2022-09-07, under approval number K222111.
What company makes Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G?
Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G is manufactured by Owen Mumford, Ltd..
What is the FDA product code for Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G?
The FDA product code for Unistik Touch Single-Use Safety Lancets - 16G, 21G, 23G, 28G and 30G 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.