Heel Incision Safety Lancet (SteriHeel 2)
K-Number: K244036 · 2025-02-26
Device Summary
Frequently Asked Questions
What is the Heel Incision Safety Lancet (SteriHeel 2)?
Heel Incision Safety Lancet (SteriHeel 2) is a medical device that received FDA 510(k) clearance on 2025-02-26. The listed applicant is SteriLance Medical (Suzhou), Inc.. The 510(k) number is K244036.
When did Heel Incision Safety Lancet (SteriHeel 2) receive FDA 510(k) clearance?
Heel Incision Safety Lancet (SteriHeel 2) received FDA 510(k) clearance on 2025-02-26, under 510(k) number K244036.
Who is the listed applicant for Heel Incision Safety Lancet (SteriHeel 2)?
The FDA 510(k) record lists SteriLance Medical (Suzhou), Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Heel Incision Safety Lancet (SteriHeel 2)?
The FDA product code for Heel Incision Safety Lancet (SteriHeel 2) is FMK.
Other records listing SteriLance Medical (Suzhou), 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.
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.