Disposable Distal Cap
Summary
Micro-Tech (Nanjing) Co., Ltd. received 510(k) clearance for Disposable Distal Cap, a FDS device. Cleared on 2025-06-27.
Details
Source
510(k) Clearance
External ID
K243388
Action Date
2025-06-27
Status
Traditional
Category
device
Product Code
FDS
Product Description
Disposable Distal Cap. Product code: FDS.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 534 device clearances issued this month. Micro-Tech (Nanjing) Co., Ltd. has received 19 total clearances in our database.
Micro-Tech (Nanjing) Co., Ltd. has 19 FDA actions in our database, including 19 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 Micro-Tech (Nanjing) Co., Ltd. have FDA actions?
Micro-Tech (Nanjing) Co., Ltd. has 19 FDA actions in our database, including 0 recalls and 19 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K243388" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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