Heel Incision Safety Lancet
Summary
SteriLance Medical (Suzhou), Inc. received 510(k) clearance for Heel Incision Safety Lancet, a FMK device. Cleared on 2021-08-26.
Details
Source
510(k) Clearance
External ID
K210745
Action Date
2021-08-26
Status
Traditional
Category
device
Product Code
FMK
Product Description
Heel Incision Safety Lancet. Product code: FMK.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. SteriLance Medical (Suzhou), Inc. has received 8 total clearances in our database.
SteriLance Medical (Suzhou), Inc. has 8 FDA actions in our database, including 8 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does SteriLance Medical (Suzhou), Inc. have FDA actions?
SteriLance Medical (Suzhou), Inc. has 8 FDA actions in our database, including 0 recalls and 8 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K210745" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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