Non absorbable Surgical Polypropylene Suture
Summary
Shandong Haidike Medical Products Co., Ltd. received 510(k) clearance for Non absorbable Surgical Polypropylene Suture, a GAW device. Cleared on 2023-09-14.
Details
Source
510(k) Clearance
External ID
K230746
Action Date
2023-09-14
Status
Traditional
Category
device
Product Code
GAW
Product Description
Non absorbable Surgical Polypropylene Suture. Product code: GAW.
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. Shandong Haidike Medical Products Co., Ltd. has received 2 total clearances in our database.
Shandong Haidike Medical Products Co., Ltd. has 2 FDA actions in our database, including 2 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 Shandong Haidike Medical Products Co., Ltd. have FDA actions?
Shandong Haidike Medical Products Co., Ltd. has 2 FDA actions in our database, including 0 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K230746" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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