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)

Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus

K-Number: K243533 · 2025-01-13

Decision Date2025-01-13
Product CodeFMK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus is the device name listed in this FDA 510(k) record. The listed applicant is Hlb Co., Ltd. Healthcare. It received FDA 510(k) clearance on 2025-01-13 under 510(k) number K243533. 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 Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus?

Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus is a medical device that received FDA 510(k) clearance on 2025-01-13. The listed applicant is Hlb Co., Ltd. Healthcare. The 510(k) number is K243533.

When did Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus receive FDA 510(k) clearance?

Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus received FDA 510(k) clearance on 2025-01-13, under 510(k) number K243533.

Who is the listed applicant for Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus?

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

What is the FDA product code for Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus?

The FDA product code for Sterilized Eol Auto Lancet; Sterilized Eol Lancet Plus 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.

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.