FDA 510(k)

Safety Lancet

K-Number: K222801 · 2023-01-25

Decision Date2023-01-25

Product CodeFMK

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Safety Lancet is the device name listed in this FDA 510(k) record. The listed applicant is Sarstedt AG & CO KG. It received FDA 510(k) clearance on 2023-01-25 under 510(k) number K222801. 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?

Safety Lancet is a medical device that received FDA 510(k) clearance on 2023-01-25. The listed applicant is Sarstedt AG & CO KG. The 510(k) number is K222801.

When did Safety Lancet receive FDA 510(k) clearance?

Safety Lancet received FDA 510(k) clearance on 2023-01-25, under 510(k) number K222801.

Who is the listed applicant for Safety Lancet?

The FDA 510(k) record lists Sarstedt AG & CO KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Safety Lancet?

The FDA product code for Safety Lancet is FMK.

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.