Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital
Summary
Unibeauty (Hubei) Technology Co., Ltd. received 510(k) clearance for Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons, a HEB device. Cleared on 2025-12-17.
Details
Source
510(k) Clearance
External ID
K253719
Action Date
2025-12-17
Status
Special
Category
device
Product Code
HEB
Product Description
Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator Tampon; Unscented Menstrual Digital Tampons. Product code: HEB.
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. Unibeauty (Hubei) Technology Co., Ltd. has received 3 total clearances in our database.
Unibeauty (Hubei) Technology Co., Ltd. has 3 FDA actions in our database, including 3 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 Unibeauty (Hubei) Technology Co., Ltd. have FDA actions?
Unibeauty (Hubei) Technology Co., Ltd. has 3 FDA actions in our database, including 0 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K253719" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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