Applicator, Absorbent Tipped, Sterile
The Sterile Absorbent Tipped Applicator is a general-purpose medical device with a sterile absorbent tip used to apply medications, clean wounds, or collect specimens in clinical settings where sterility is required. It is classified as FDA Class 1, the lowest risk category, subject only to general controls, with no premarket submission required. The product code is KXG, regulated under 21 CFR 880.6025, in the General Hospital medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- KXG
- Device Class
- FDA class 1
- Regulation Number
- 880.6025
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K802004 | PROFILE SWAB CAT.#5273 & 5274 | Sep 16, 1980 | Substantially Equivalent | Pollak (Intl.), Ltd. |
FEI Numbers
This FDA classification entry is associated with 279 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 279 registration numbers. Click on an entry to view related FDA registrations.