Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Tenderfoot

K-Number: K223352 · 2023-03-02

ApplicantAccriva Diagnostics, Inc.
Decision Date2023-03-02
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Tenderfoot is the device name listed in this FDA 510(k) record. The listed applicant is Accriva Diagnostics, Inc.. It received FDA 510(k) clearance on 2023-03-02 under 510(k) number K223352. 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 Tenderfoot?

Tenderfoot is a medical device that received FDA 510(k) clearance on 2023-03-02. The listed applicant is Accriva Diagnostics, Inc.. The 510(k) number is K223352.

When did Tenderfoot receive FDA 510(k) clearance?

Tenderfoot received FDA 510(k) clearance on 2023-03-02, under 510(k) number K223352.

Who is the listed applicant for Tenderfoot?

The FDA 510(k) record lists Accriva Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tenderfoot?

The FDA product code for Tenderfoot is FMK.

Other records listing Accriva Diagnostics, Inc. as applicant

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.

K202101GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Level 1 and Level 2K193041Hemochron Signature Elite

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.

↑